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Major Bacitracin

Bacitracin Zinc · 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

Major Bacitracin

Generic name

Bacitracin Zinc

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Major Pharmaceuticals

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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	500 [USP'U]/g	1648110	View
Bacitracin Zinc	500 [USP'U]/g	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

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@FDA NDC Directory

Application number

000004

Application type

Approval date

July 16, 1969

Sponsor

PHARMICS

Products on application

Submissions recorded

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 20241217). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241217 HUMAN OTC DRUG · 20240308

Indications and Usage

openFDA Drug Labeling

Uses First Aid to help prevent infection in minor cuts scrapes burns

Purpose

openFDA Drug Labeling

Purpose First Aid Antibiotic

Dosage and Administration

openFDA Drug Labeling

Directions Clean the affected area and dry thoroughly Apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily May be covered with a sterile bandage

Warnings

openFDA Drug Labeling

Warnings For External Use Only.

Do Not Use

openFDA Drug Labeling

Do Not Use in eyes over large areas of the body if you are allergic to any of the ingredients, due to the possiblity of anaphylactic shock longer than 1 week unless directed by a doctor

Ask a Doctor

openFDA Drug Labeling

Ask Doctor before Use if you have deep or puncture wounds, animal bites or serious burns.

Stop Use

openFDA Drug Labeling

Stop Use and Ask Doctor if Before use in case of deep puncture wounds, animal bites or serious burns The condition persists or gets worse A rash or allergic reaction develops

Active Ingredient

openFDA Drug Labeling

Active Ingredient Bacitracin Zinc 500 Units per gram

Adverse event reports

Source: openFDA FAERS

4,414

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: BACITRACIN. 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
0904-7023-67	0904-7023	Major Pharmaceuticals	144 PACKET in 1 CARTON (0904-7023-67) / .9 g in 1 PACKET	May 29, 2020
0904-7402-67	0904-7402	Major Pharmaceuticals	144 PACKET in 1 CARTON (0904-7402-67) / .9 g in 1 PACKET	March 8, 2024
0904-7023	0904-7023	Major Pharmaceuticals	—	April 1, 2020
0904-7402	0904-7402	Major Pharmaceuticals	—	March 8, 2024

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.