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Over-the-counter medicine · no prescription needed

Diphenhydramine and ibuprofen

Purpose on the label: Nighttime sleep-aid Pain reliever

Sleep aids

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Diphenhydramine and ibuprofen used for?
The Drug Facts label of Pain Relief Pm (Bionpharma Inc.) lists these uses: for relief of occasional sleeplessness when associated with minor aches and pains; helps you fall asleep and stay asleep.
Do I need a prescription for Diphenhydramine and ibuprofen?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Diphenhydramine and ibuprofen been recalled?
FDA enforcement reports list 2 recalls of products on this page; the newest started April 16, 2015. A recall usually concerns specific products or lots, not every brand.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Pain Relief Pm · Bionpharma Inc.

Diphenhydramine hydrochloride 25 mg · Ibuprofen 200 mg, capsule, liquid filled (oral)

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid Pain reliever

Uses

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night’s sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are

  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor's care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 capsules at bedtime
  • do not take more than 2 capsules in 24 hours

Inactive ingredients

gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions?

call toll-free 1-888-235-2466

— FDA label of Pain Relief Pm, Bionpharma Inc., effective May 4, 2026. See the official label on DailyMed →

Good Neighbor Pharmacy Ibuprofen Pm · Amerisource Bergen

Diphenhydramine citrate 38 mg · Ibuprofen 200 mg, tablet, film coated (oral)

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid Pain reliever

Uses

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night’s sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are

  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor’s care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions?

1-800-719-9260

— FDA label of Good Neighbor Pharmacy Ibuprofen Pm, Amerisource Bergen, effective May 15, 2026. See the official label on DailyMed →

Advil PM · Navajo Manufacturing Company Inc.

Diphenhydramine citrate 38 mg · Ibuprofen 200 mg, tablet, coated (oral)

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purposes Nighttime sleep-aid Pain reliever

Purpose

Nighttime sleep-aid Pain reliever

Uses

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • rash
  • skin reddening
  • blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night’s sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are

  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor’s care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours

Inactive ingredients

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

Call toll free 1-800-88-ADVIL

— FDA label of Advil PM, Navajo Manufacturing Company Inc., effective April 8, 2026. See the official label on DailyMed →

Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg · PLD Acquisitions LLC DBA Avma Pharma Solutions

Diphenhydramine citrate 38 mg · Ibuprofen 200 mg, tablet (oral)

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid Pain reliever

Uses

for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning : NSAIDs except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain

Ask a doctor before use if

stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin take any other drug

When using this product

drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying illness redness or swelling is present in the painful area any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than directed adults and childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

Inactive ingredients

carnauba wax, corn starch, croscarmellose sodium, FD&C blue #2, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

— FDA label of Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg, PLD Acquisitions LLC DBA Avma Pharma Solutions, effective April 24, 2024. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Diphenhydramine hydrochloride 25 mg · Ibuprofen 200 mg · capsule, liquid filled (oral) · 22 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Advil Pm Haleon US Holdings LLC DailyMed
Diphenhydramine HCl and Ibuprofen Aurohealth LLC DailyMed
Ibuprofen and Diphenhydramine HCl Valu Merchandisers Company DailyMed
Ibuprofen PM Chain Drug Marketing Association Inc. DailyMed
Ibuprofen PM CVS Pharmacy DailyMed
Ibuprofen PM Heb DailyMed
Ibuprofen PM Kroger Company DailyMed
Ibuprofen PM Meijer Distribution Inc. DailyMed
Ibuprofen PM Premier Value Alliance LLC DailyMed
Ibuprofen PM TOP CARE (Topco Associates LLC) DailyMed
Ibuprofen PM Wal-Mart Stores, Inc. DailyMed
Ibuprofen PM Walgreen Company DailyMed
Ibuprofen PM Whole Foods Market, Inc. DailyMed
Ibuprofen, Diphenhydramine HCL Bionpharma Inc. DailyMed
Ibuprofen, Diphenhydramine HCL Rite Aid Corporation DailyMed
Ibuprofen, Diphenhydramine HCL TARGET Corporation DailyMed
Pain Relief Pm Bionpharma Inc. DailyMed
Diphenhydramine citrate 38 mg · Ibuprofen 200 mg · tablet, film coated (oral) · 21 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Basic Care Ibuprofen Pm Amazon.com Services LLC DailyMed
Care One Ibuprofen PM American Sales Company DailyMed
dg health Ibuprofen pm Dolgencorp Inc DailyMed
Equaline Ibuprofen Pm United Natural Foods, Inc. dba UNFI DailyMed
Equate Ibuprofen Pm Wal-Mart Stores Inc DailyMed
Exchange Select Ibuprofen PM Army & Air Force Exchange Service DailyMed
Foster and Thrive Ibuprofen Pm Strategic Sourcing Services LLC DailyMed
Good Neighbor Pharmacy Ibuprofen Pm Amerisource Bergen DailyMed
Good Sense Ibuprofen Pm L. Perrigo Company DailyMed
Ibuprofen Pm CVS Pharmacy DailyMed
Ibuprofen Pm H E B DailyMed
Ibuprofen Pm HyVee Inc DailyMed
Ibuprofen Pm Kroger Company DailyMed
Ibuprofen PM Meijer Distribution Inc DailyMed
Ibuprofen Pm Publix Super Markets Inc —
Ibuprofen Pm Rite Aid Corporation DailyMed
Ibuprofen Pm Safeway DailyMed
Ibuprofen PM Walgreen Company DailyMed
Leader Ibuprofen PM Cardinal Health 110, LLC. dba Leader DailyMed
Topcare Ibuprofen PM Topco Associates LLC DailyMed
Up and Up Ibuprofen Pm Target Corporation DailyMed
Diphenhydramine citrate 38 mg · Ibuprofen 200 mg · tablet, coated (oral) · 18 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Advil Pm Haleon US Holdings LLC DailyMed
Advil PM Lil' Drug Store Products, Inc. DailyMed
Advil PM Navajo Manufacturing Company Inc. DailyMed
Advil Pm Select Consumer Group DailyMed
Advil PM, CVP HEALTH Lil' Drug Store Products, Inc. DailyMed
Advil PM, TRAVEL BASIX Lil' Drug Store Products, Inc. DailyMed
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated Lil Drug Store Products, Inc DailyMed
Amazon Basic Care Ibuprofen Pm Amazon.com Services LLC DailyMed
Ibuprofen and Diphenhydramine Citrate Aurohealth LLC DailyMed
Ibuprofen and Diphenhydramine Citrate Better Living Brands, LLC DailyMed
Ibuprofen PM Family Dollar (FAMILY WELLNESS) DailyMed
Ibuprofen PM Kroger Company DailyMed
Ibuprofen PM Safeway, Inc. DailyMed
Ibuprofen PM WALMART INC. (see also Equate) DailyMed
Ibuprofen PM WR Group, Inc. DailyMed
Motrin PM Kenvue Brands LLC DailyMed
Diphenhydramine citrate 38 mg · Ibuprofen 200 mg · tablet (oral) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg PLD Acquisitions LLC DBA Avma Pharma Solutions DailyMed
Ibuprofen and Diphenhydramine Citrate Dr. Reddy's Laboratories Limited DailyMed

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Diphenhydramine and ibuprofen, by strength and form
Strength and formGeneric or brandPharmacies pay
diphenhydramine citrate 38 mg · ibuprofen 200 mg
tablet, film coated
Generic $0.1298 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Lil' Drug Store Products, Inc.6 products
  • Aurohealth LLC4 products
  • Haleon US Holdings LLC3 products
  • Kroger Company3 products
  • Bionpharma Inc.3 products
  • Wal-Mart Stores, Inc.2 products
  • Walgreen Company2 products
  • Meijer Distribution Inc.2 products
  • CVS Pharmacy2 products
  • Amazon.com Services LLC2 products
  • TARGET Corporation2 products
  • Rite Aid Corporation2 products
  • TOP CARE (Topco Associates LLC)2 products
  • Safeway, Inc.1 product
  • American Sales Company1 product
  • Amerisource Bergen1 product
  • Publix Super Markets Inc1 product
  • Select Consumer Group1 product
  • Kenvue Brands LLC1 product
  • HyVee Inc1 product
  • WR Group, Inc.1 product
  • Army & Air Force Exchange Service1 product
  • Family Dollar (FAMILY WELLNESS)1 product
  • Better Living Brands, LLC1 product
  • Topco Associates LLC1 product
  • Cardinal Health 110, LLC. dba Leader1 product
  • Safeway1 product
  • H E B1 product
  • United Natural Foods, Inc. dba UNFI1 product
  • Dolgencorp Inc1 product

Showing the 30 companies with the most products, of 41.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. April 16, 2015 · Class II · Terminated · D-967-2015

    Products failed the Antimicrobial Effectiveness Test

    Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) — Tarmac Products, Inc.

  2. February 26, 2014 · Class III · Terminated · D-1166-2014

    Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

    Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 — Pfizer Us Pharmaceutical Group

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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