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Bacitracin Zinc

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
Bacitracin Zinc
Generic name
Bacitracin Zinc
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
Trifecta Pharmaceuticals USA LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
18
Packages
31
Data completeness
82% 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
Bacitracin Zinc 500 [iU]/g 204602 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
49

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 20260807). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260807 HUMAN OTC DRUG · 20260410 HUMAN OTC DRUG · 20251125 HUMAN OTC DRUG · 20251030

Indications and Usage

openFDA Drug Labeling

Use(s) First aid to help prevent infection in minor cuts, scrapes, and 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 this 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 • In the eyes or over large areas of the body • If you are allergic to any of the ingredients • Longer than 1 week unless directed by a doctor When using this product there are no side effects. Ask a doctor or pharmacist before use if you have deep or punction wounds, animal bites, or serious burns Stop use and ask a doctor if • The condition persists or gets worse • A rash or other allergic reaction develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Before using, consult a doctor if you have deep or puncture wounds animal bites serious burns

Stop Use

openFDA Drug Labeling

STOP USE and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persists for more than 1 week or clear up and occur again within a few days a rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT(S) (in each gram) Bacitracin zinc, USP 500 units ............. First aid antibiotic

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-4706 NDC: 50090-4706-0 15 g in a TUBE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS
4,395
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 ZINC. 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
50090-4706-0 50090-4706 A-S Medication Solutions 1 TUBE in 1 CARTON (50090-4706-0) / 15 g in 1 TUBE November 11, 2019
87236-001-01 87236-001 Aldermed Inc. 1 TUBE in 1 CARTON (87236-001-01) / 28.4 g in 1 TUBE November 1, 2025
87236-001-09 87236-001 Aldermed Inc. .9 g in 1 PACKET (87236-001-09) November 1, 2025
87236-001-14 87236-001 Aldermed Inc. 1 TUBE in 1 CARTON (87236-001-14) / 14.2 g in 1 TUBE November 1, 2025
87236-001-15 87236-001 Aldermed Inc. 425 g in 1 JAR (87236-001-15) November 1, 2025
87236-001-44 87236-001 Aldermed Inc. 144 PACKET in 1 CARTON (87236-001-44) / .9 g in 1 PACKET November 1, 2025
68001-531-45 68001-531 BluePoint Laboratories 1 TUBE in 1 CARTON (68001-531-45) / 14.2 g in 1 TUBE March 4, 2022
68001-531-46 68001-531 BluePoint Laboratories 1 TUBE in 1 CARTON (68001-531-46) / 28.4 g in 1 TUBE March 4, 2022
83324-040-01 83324-040 Chain Drug Marketing Association Inc. 1 TUBE in 1 BOX (83324-040-01) / 28.3 g in 1 TUBE June 11, 2024
67777-008-10 67777-008 Dynarex Corporation 12 BOX in 1 CASE (67777-008-10) / 144 PACKET in 1 BOX (67777-008-11) / .9 g in 1 PACKET February 16, 2018
67777-008-20 67777-008 Dynarex Corporation 72 BOX in 1 CASE (67777-008-20) / 1 TUBE in 1 BOX (67777-008-21) / 14.2 g in 1 TUBE February 16, 2018
67777-008-30 67777-008 Dynarex Corporation 72 BOX in 1 CASE (67777-008-30) / 1 TUBE in 1 BOX (67777-008-31) / 28.4 g in 1 TUBE February 16, 2018
67777-008-50 67777-008 Dynarex Corporation 72 BOX in 1 CASE (67777-008-50) / 1 TUBE in 1 BOX (67777-008-51) / 113 g in 1 TUBE February 16, 2018
67777-008-60 67777-008 Dynarex Corporation 12 JAR in 1 CASE (67777-008-60) / 425 g in 1 JAR (67777-008-61) February 16, 2018
49035-510-26 49035-510 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 TUBE in 1 CARTON (49035-510-26) / 28 g in 1 TUBE August 7, 2017
21922-091-04 21922-091 Encube Ethicals, Inc. 1 TUBE in 1 CARTON (21922-091-04) / 14 g in 1 TUBE March 13, 2025
21922-091-05 21922-091 Encube Ethicals, Inc. 1 TUBE in 1 CARTON (21922-091-05) / 28 g in 1 TUBE March 13, 2025
57896-145-14 57896-145 Geri-Care Pharmaceuticals, Corp. 144 PACKET in 1 CARTON (57896-145-14) / .9 g in 1 PACKET April 1, 2022
0404-0170-50 0404-0170 Henry Schein 72 BOX in 1 CASE (0404-0170-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE November 7, 2022
0404-0172-50 0404-0172 Henry Schein 1728 BOX in 1 CASE (0404-0172-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET November 7, 2022
0536-1263-28 0536-1263 Rugby Laboratories 1 TUBE in 1 BOX (0536-1263-28) / 28 g in 1 TUBE April 15, 2020
70677-1211-1 70677-1211 STRATEGIC SOURCING SERVICES LLC 1 TUBE in 1 CARTON (70677-1211-1) / 28.4 g in 1 TUBE December 15, 2023
58980-011-01 58980-011 STRATUS PHARMACEUTICALS INC 144 PACKET in 1 BOX (58980-011-01) / 1 g in 1 PACKET May 15, 2020
58980-011-10 58980-011 STRATUS PHARMACEUTICALS INC 1 TUBE in 1 BOX (58980-011-10) / 28.35 g in 1 TUBE September 15, 2017
51672-2075-1 51672-2075 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2075-1) / 15 g in 1 TUBE May 11, 2006
51672-2075-2 51672-2075 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2075-2) / 30 g in 1 TUBE May 11, 2006
69396-098-09 69396-098 Trifecta Pharmaceuticals USA LLC 144 PACKET in 1 CARTON (69396-098-09) / .9 g in 1 PACKET March 10, 2022
69396-104-09 69396-104 Trifecta Pharmaceuticals USA LLC 144 PACKET in 1 CARTON (69396-104-09) / .9 g in 1 PACKET April 21, 2020
69396-104-25 69396-104 Trifecta Pharmaceuticals USA LLC 25 PACKET in 1 CARTON (69396-104-25) / .9 g in 1 PACKET March 14, 2022
69396-163-09 69396-163 Trifecta Pharmaceuticals USA LLC 144 PACKET in 1 CARTON (69396-163-09) / .9 g in 1 PACKET June 5, 2025
52000-059-03 52000-059 Universal Distribution Center LLC 1 TUBE in 1 CARTON (52000-059-03) / 14 g in 1 TUBE December 9, 2020
50090-4706 50090-4706 A-S Medication Solutions — May 11, 2006
87236-001 87236-001 Aldermed Inc. — November 1, 2025
68001-531 68001-531 BluePoint Laboratories — March 4, 2022
83324-040 83324-040 Chain Drug Marketing Association Inc. — June 11, 2024
67777-008 67777-008 Dynarex Corporation — February 16, 2018
49035-510 49035-510 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — August 7, 2017
21922-091 21922-091 Encube Ethicals, Inc. — March 13, 2025
57896-145 57896-145 Geri-Care Pharmaceuticals, Corp. — April 1, 2022
0404-0170 0404-0170 Henry Schein — November 7, 2022
0404-0172 0404-0172 Henry Schein — November 7, 2022
0536-1263 0536-1263 Rugby Laboratories — April 15, 2020
70677-1211 70677-1211 STRATEGIC SOURCING SERVICES LLC — December 15, 2023
58980-011 58980-011 STRATUS PHARMACEUTICALS INC — September 15, 2017
51672-2075 51672-2075 Sun Pharmaceutical Industries, Inc. — May 11, 2006
69396-098 69396-098 Trifecta Pharmaceuticals USA LLC — March 10, 2022
69396-104 69396-104 Trifecta Pharmaceuticals USA LLC — April 21, 2020
69396-163 69396-163 Trifecta Pharmaceuticals USA LLC — June 5, 2025
52000-059 52000-059 Universal Distribution Center LLC — December 9, 2020

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.