Tetrahydrozoline

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.

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 ingredient, 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.

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, Inc4 products
• Strategic Sourcing Services LLC2 products
• HEB Grocery Company, LP1 product
• Meijer Distribution, Inc.1 product
• KC Pharmaceuticals, Inc.1 product
• Dolgencorp LLC1 product
• Topco Associates LLC1 product
• Kenvue Brands LLC1 product
• Chain Drug Marketing Assoc., Inc.1 product
• United Natural Foods, Inc.1 product
• Family Dollar Services, Inc.1 product
• KC Pharmaceuticals1 product
• Salado Sales, Inc.1 product
• Kinray1 product
• Geiss, Destin & Dunn, Inc.1 product
• Discount Drug Mart, Inc.1 product
• Walgreens Company1 product
• Harris Teeter, LLC.P1 product
• Walmart, Inc.1 product
• The Kroger Co.1 product
• Valu Merchandisers Company1 product
• Walmart1 product
• WinCo Foods, LLC1 product

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. September 11, 2026 · Class II · Ongoing · D-0007-2027

   Lack of Assurance of Sterility

   Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106 — K.C. Pharmaceuticals, Inc.

2. March 3, 2026 · Class II · Ongoing · D-0413-2026

   Lack of Assurance of Sterility

   Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804 — K.C. Pharmaceuticals, Inc

3. June 13, 2023 · Class II · Ongoing · D-0898-2023

   CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

   Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL — K.C. Pharmaceuticals, Inc

4. June 13, 2023 · Class II · Ongoing · D-0897-2023

   CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

   Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 — K.C. Pharmaceuticals, Inc

5. December 4, 2014 · Class III · Terminated · D-0320-2015

   CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

   Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Dist — K C Pharmaceuticals Inc

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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