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Brand-name over-the-counter medicine

Mucinex

Generic names: Guaifenesin · Dextromethorphan and guaifenesin · Guaifenesin and pseudoephedrine · Acetaminophen, dextromethorphan, phenylephrine and triprolidine · Dextromethorphan, guaifenesin and phenylephrine · Dextromethorphan · Acetaminophen, dextromethorphan and triprolidine · Acetaminophen and guaifenesin · Acetaminophen, dextromethorphan, guaifenesin and phenylephrine · Acetaminophen and dextromethorphan · Oxymetazoline

FDA application holder: Reckitt Benckiser

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

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

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

Quick answers

What is Mucinex?
Mucinex is a brand name of Guaifenesin, Dextromethorphan and guaifenesin, Guaifenesin and pseudoephedrine, Acetaminophen, dextromethorphan, phenylephrine and triprolidine, Dextromethorphan, guaifenesin and phenylephrine, Dextromethorphan, Acetaminophen, dextromethorphan and triprolidine, Acetaminophen and guaifenesin, Acetaminophen, dextromethorphan, guaifenesin and phenylephrine, Acetaminophen and dextromethorphan and Oxymetazoline, an over-the-counter medicine. The FDA NDC Directory lists 46 Mucinex products in 20 strengths and forms.
Who makes Mucinex?
Reckitt Benckiser holds the FDA application for Mucinex (NDA021282, approved July 12, 2002). 12 other companies (repackagers or distributors) also list Mucinex products.
Is there a generic or store brand of Mucinex?
Yes. The FDA NDC Directory lists 394 other products with the same active ingredients, strength and form as a Mucinex product, 391 of them generic or store brands. Ask your pharmacist whether one is right for you.
Has Mucinex been recalled?
FDA enforcement reports list 2 recalls of Mucinex products; the newest started April 15, 2015. A recall usually concerns specific lots, not every product.

What Mucinex is

Each Mucinex product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Guaifenesin · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
guaifenesin 1200 mg
tablet, extended release (oral)
Mucinex Maximum Strength 54 products, 42 companies DailyMed
guaifenesin 600 mg
tablet, extended release (oral)
Mucinex 55 products, 45 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Guaifenesin →

Dextromethorphan and guaifenesin · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
dextromethorphan hydrobromide 10 mg · guaifenesin 200 mg
capsule, liquid filled (oral)
Mucinex Cough Chest Congestion 8 products, 8 companies —
dextromethorphan hydrobromide 20 mg/20 mL · guaifenesin 400 mg/20 mL
solution (oral)
Mucinex Fast-Max DM Max 58 products, 32 companies —
dextromethorphan hydrobromide 30 mg · guaifenesin 600 mg
tablet, extended release (oral)
Mucinex DM 44 products, 35 companies DailyMed
dextromethorphan hydrobromide 5 mg/5 mL · guaifenesin 100 mg/5 mL
solution (oral)
Mucinex Childrens Cough 3 products, 3 companies DailyMed
dextromethorphan hydrobromide 60 mg · guaifenesin 1200 mg
tablet, extended release (oral)
Mucinex DM Maximum Strength 57 products, 44 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Dextromethorphan and guaifenesin →

Guaifenesin and pseudoephedrine · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
guaifenesin 1200 mg · pseudoephedrine hydrochloride 120 mg
tablet, extended release (oral)
Mucinex D Maximum Strength 10 products, 10 companies DailyMed
guaifenesin 600 mg · pseudoephedrine hydrochloride 60 mg
tablet, extended release (oral)
Mucinex D 20 products, 16 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Guaifenesin and pseudoephedrine →

Acetaminophen, dextromethorphan, phenylephrine and triprolidine · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 650 mg/20 mL · dextromethorphan hydrobromide 20 mg/20 mL · phenylephrine hydrochloride 10 mg/20 mL · triprolidine hydrochloride 2.5 mg/20 mL
solution (oral)
Mucinex Night Time Severe Cold and Flu, Mucinex Nightshift Severe Cold and Flu, Mucinex Nightshift Sinus 2 products, 2 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan, phenylephrine and triprolidine →

Dextromethorphan, guaifenesin and phenylephrine · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
dextromethorphan hydrobromide 5 mg/5 mL · guaifenesin 100 mg/5 mL · phenylephrine hydrochloride 2.5 mg/5 mL
solution (oral)
Childrens Mucinex Multi-Symptom Cold 9 products, 7 companies —
dextromethorphan hydrobromide 5 mg/5 mL · guaifenesin 100 mg/5 mL · phenylephrine hydrochloride 2.5 mg/5 mL
suspension (oral)
Mucinex Childrens Cough and Congestion, Mucinex Childrens Multi-Symptom Cold 2 products, 2 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Dextromethorphan, guaifenesin and phenylephrine →

Dextromethorphan · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
dextromethorphan hydrobromide 10 mg
tablet, chewable (oral)
Mucinex Childrens Mighty Chews Cough 1 product, 1 company DailyMed
dextromethorphan hydrobromide 5 mg
lozenge (oral)
Mucinex Instasoothe Cough None listed DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Dextromethorphan →

Acetaminophen, dextromethorphan and triprolidine · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 650 mg/20 mL · dextromethorphan hydrobromide 20 mg/20 mL · triprolidine hydrochloride 2.5 mg/20 mL
solution (oral)
Mucinex Nightshift Cold and Flu, Mucinex Fast-Max Nighttime Cold and Flu 10 products, 9 companies —

Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan and triprolidine →

Acetaminophen and guaifenesin · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 325 mg · guaifenesin 200 mg
capsule, liquid filled (oral)
Mucinex Cold and Flu, Mucinex Sinus Max Clear and Cool 4 products, 4 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and guaifenesin →

Acetaminophen, dextromethorphan, guaifenesin and phenylephrine · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 325 mg · dextromethorphan hydrobromide 10 mg · guaifenesin 200 mg · phenylephrine hydrochloride 5 mg
tablet, film coated (oral)
Mucinex Fast-Max Cold and Flu 51 products, 29 companies DailyMed
acetaminophen 325 mg/10 mL · dextromethorphan hydrobromide 10 mg/10 mL · guaifenesin 200 mg/10 mL · phenylephrine hydrochloride 5 mg/10 mL
solution (oral)
Mucinex Childrens Cold and Flu 3 products, 2 companies DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan, guaifenesin and phenylephrine →

Acetaminophen and dextromethorphan · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 325 mg · dextromethorphan hydrobromide 10 mg
tablet (oral)
Mucinex Fast-Max Cold and Flu 1 product, 1 company —

Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and dextromethorphan →

Oxymetazoline · over-the-counter medicine

Strength and formProduct namesSame medicine, other namesLabel
oxymetazoline hydrochloride 0.05%
solution (nasal)
MUCINEX Childrens Stuffy Nose 2 products, 1 company DailyMed

Its page quotes the Drug Facts label and lists every brand and store brand: Oxymetazoline →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Mucinex products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA021282Reckitt BenckiserJuly 12, 200214
NDA021620Reckitt BenckiserApril 29, 20049
NDA021585Reckitt BenckiserJune 22, 20044

Companies that list Mucinex

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Mucinex products.

Showing 10 of 13 companies.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. April 15, 2015 · Class II · Terminated · D-1369-2015

    Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result cert

    Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-0 — Reckitt Benckiser LLC

  2. November 10, 2014 · Class III · Terminated · D-0964-2015

    Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

    Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England — Reckitt Benckiser LLC

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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