Benadryl Allergy Liqui-Gels

DIPHENHYDRAMINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

Benadryl Allergy Liqui-Gels is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Kenvue Brands LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260507.

Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Kenvue Brands LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
50580-228
Application
M012
Label effective
20260507

About this product

Benadryl Allergy Liqui-Gels is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50580-228, application M012, label effective 20260507. It is one of 66 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DIPHENHYDRAMINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, symptoms due, runny nose, hay fever, upper respiratory, sneezing itchy, watery eyes, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage & Administration

Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product in children under 6 years of age

Warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. 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)

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How products containing DIPHENHYDRAMINE HYDROCHLORIDE compare

FDA lists 66 drug label records with DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — CVS Pharmacy,Inc. 5
— — Advance Pharmaceutical Inc. 4
— — Cardinal Health 107, LLC 4
— — Medical Purchasing Solutions, LLC 4
— — Health Pharma USA LLC 3

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0121-2026 TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. Kenvue Brands LLC Class II Ongoing 20251105

Frequently asked questions

What is Benadryl Allergy Liqui-Gels used for?
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Who makes Benadryl Allergy Liqui-Gels?
Kenvue Brands LLC is the labeler of record for Benadryl Allergy Liqui-Gels. 66 FDA label records share the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Benadryl Allergy Liqui-Gels come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Benadryl Allergy Liqui-Gels prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HYDROCHLORIDE?
Yes. 66 FDA drug label records list DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Benadryl Allergy Liqui-Gels been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.