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Bacitracin Zinc Antibiotic Ointment · Ointment

Over-the-counter M Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Equate
Generic name
Bacitracin Zinc Antibiotic Ointment
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
Walmart Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Bacitracin Zinc 500 [USP'U]/g 204602 View
Camphor (SYNTHETIC) 4.8 g/100g 1793147 —
Eucalyptus Oil 1.2 g/100g 1547992 —
Menthol 2.6 g/100g 1947261 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Cell Wall Synthesis & Repair [PE] PE All 41 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
000004
Application type
M
Approval date
July 16, 1969
Sponsor
PHARMICS
Products on application
1
Submissions recorded
3
Products approved under application 000004.
Product Trade name Form Strength Ingredient Status TE Flags
000004-004 PAREDRINE SOLUTION/DROPS HYDROXYAMPHETAMINE HYDROBROMIDE Discontinued —

Approval history

Source: Drugs@FDA
Most recent submissions on application 000004.
Type No. Action Status Date Review
Supplement 11 Labeling Approved May 26, 1987 —
Supplement 10 Labeling Approved May 8, 1980 —
Original application 1 Approved July 16, 1969 Unknown

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251008). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251008 HUMAN OTC DRUG · 20250201

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves cough due to minor throat and bronchial irritation associated with a cold temporarily relieves minor aches and pains of muscles and joints

Purpose Cough suppressant & topical analgesic

Dosage and Administration

openFDA Drug Labeling

Directions See important warnings under "When using this product" • adults and children 2 years and over: > Rub a thick layer on the throat and chest for cough, or rub on sore aching muscles or joints > Clothing should be left loose about the throat and chest to help vapors reach the nose and mouth > Use up to 3 times daily or as directed by doctor Cover with a warm, dry cloth if desired • children under 2 years: do not use

Warnings For external use only; avoid contact with eyes. Do not use by mouth in nostrils on wounds or damaged skin with tight bandages Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema When using this product, do not heat microwave add to hot water or any container where heating water. May cause splattering and result in burns. Stop use and ask a doctor if muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days. cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE if you are allergic to any of the ingredients in the eyes over large areas of the body

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days. cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredients Camphor (synthetic) 4.8% .....................................................Cough suppressant & topical analgesic Eucalyptus Oil 1.2% .............................................................. Cough suppressant Menthol 2.6% .........................................................................Cough suppressant & topical analgesic

Adverse event reports

Source: openFDA FAERS
54,494
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MENTHOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
79903-194-17 79903-194 Walmart Inc 1 JAR in 1 CARTON (79903-194-17) / 50 g in 1 JAR August 1, 2023
79903-372-01 79903-372 Walmart Inc. 1 TUBE in 1 CARTON (79903-372-01) / 28 g in 1 TUBE January 27, 2025
79903-194 79903-194 Walmart Inc — August 1, 2023
79903-372 79903-372 Walmart Inc. — January 27, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.