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Bacitracin

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
Generic name
Bacitracin
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
Preferred Pharmaceuticals Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
24
Packages
38
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 500 U/g 1648110 View
Bacitracin 500 [USP'U]/1000mg 1648110 View
Bacitracin 500 [USP'U]/g 1648110 View
Bacitracin 500 [iU]/g 1648110 View
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
62

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 20251201). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251201 HUMAN OTC DRUG · 20241112 HUMAN OTC DRUG · 20240923 HUMAN OTC DRUG · 20240101

Indications and Usage

openFDA Drug Labeling

DIRECTION Clean the affected area. 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.

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Dosage and Administration

openFDA Drug Labeling

dosage and administration Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Warnings: For external use only Dosage and Administration: • clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage Stop use and ask a doctor if • the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use: • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away

DO NOT USE 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.

DO NOT USE Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.

Ask a Doctor

openFDA Drug Labeling

ASK A DOCTOR Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

ACTIVE INGRIDIENT Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Bacitracin First Aid Antibiotic Ointment NDC 72162-2280-2: 144 Unit dose Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

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
50090-0815-0 50090-0815 A-S Medication Solutions 1 TUBE in 1 CARTON (50090-0815-0) / 14 g in 1 TUBE November 28, 2014
50090-0845-0 50090-0845 A-S Medication Solutions 144 PACKET in 1 CARTON (50090-0845-0) / .9 g in 1 PACKET November 28, 2014
84387-002-01 84387-002 ALLIED TRADE LINK LLC 28.4 g in 1 TUBE (84387-002-01) October 24, 2024
87236-000-01 87236-000 AlderMed Inc. 1 TUBE in 1 CARTON (87236-000-01) / 28.4 g in 1 TUBE November 1, 2025
87236-000-02 87236-000 AlderMed Inc. .9 g in 1 PACKET (87236-000-02) November 1, 2025
87236-000-14 87236-000 AlderMed Inc. 1 TUBE in 1 CARTON (87236-000-14) / 14.2 g in 1 TUBE November 1, 2025
87236-000-44 87236-000 AlderMed Inc. 144 PACKET in 1 CARTON (87236-000-44) / .9 g in 1 PACKET November 1, 2025
68001-477-46 68001-477 BluePoint Laboratories 1 TUBE in 1 CARTON (68001-477-46) / 14.2 g in 1 TUBE November 24, 2020
68001-477-47 68001-477 BluePoint Laboratories 1 TUBE in 1 CARTON (68001-477-47) / 28.4 g in 1 TUBE November 24, 2020
68001-477-48 68001-477 BluePoint Laboratories 1 PACKET in 1 CARTON (68001-477-48) / .9 g in 1 PACKET (68001-477-45) November 24, 2020
71335-2731-1 71335-2731 Bryant Ranch Prepack 144 PACKET in 1 CARTON (71335-2731-1) / .9 g in 1 PACKET July 30, 2025
72162-2280-2 72162-2280 Bryant Ranch Prepack 144 PACKET in 1 CARTON (72162-2280-2) / .9 g in 1 PACKET September 6, 2024
59779-536-64 59779-536 CVS Pharmacy 1 TUBE in 1 CARTON (59779-536-64) / 28 g in 1 TUBE June 8, 2005
0713-0280-31 0713-0280 Cosette Pharmaceuticals, Inc. 28.4 g in 1 TUBE (0713-0280-31) January 10, 1995
67777-116-10 67777-116 Dynarex Corporation 1728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET September 12, 2016
67777-116-20 67777-116 Dynarex Corporation 72 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21) September 12, 2016
67777-116-30 67777-116 Dynarex Corporation 72 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE September 12, 2016
37808-536-64 37808-536 H E B 1 TUBE in 1 CARTON (37808-536-64) / 28 g in 1 TUBE June 15, 1991
41226-880-02 41226-880 Kroger 1 TUBE in 1 CARTON (41226-880-02) / 28 g in 1 TUBE November 15, 2025
30142-536-64 30142-536 Kroger Company 1 TUBE in 1 CARTON (30142-536-64) / 28 g in 1 TUBE April 19, 2017
41250-844-64 41250-844 Meijer Distribution Inc 1 TUBE in 1 CARTON (41250-844-64) / 28 g in 1 TUBE October 24, 2018
68071-5253-3 68071-5253 NuCare Pharmaceuticals,Inc. 28.4 g in 1 BOX (68071-5253-3) May 8, 2020
45802-060-01 45802-060 Padagis Israel Pharmaceuticals Ltd 1 TUBE in 1 CARTON (45802-060-01) / 14 g in 1 TUBE September 1, 2011
45802-060-03 45802-060 Padagis Israel Pharmaceuticals Ltd 1 TUBE in 1 CARTON (45802-060-03) / 28 g in 1 TUBE August 5, 2011
45802-060-70 45802-060 Padagis Israel Pharmaceuticals Ltd 144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET June 20, 2011
68788-4153-2 68788-4153 Preferred Pharmaceuticals Inc. 1 TUBE in 1 BOX (68788-4153-2) / 28 g in 1 TUBE July 15, 2026
68788-8643-2 68788-8643 Preferred Pharmaceuticals Inc. 28.4 g in 1 TUBE (68788-8643-2) April 30, 2024
68788-9794-2 68788-9794 Preferred Pharmaceuticals, Inc 28 g in 1 TUBE (68788-9794-2) April 30, 2012
63187-299-01 63187-299 Proficient Rx LP 28.35 g in 1 TUBE (63187-299-01) January 1, 2019
71205-057-01 71205-057 Proficient Rx LP 28.4 g in 1 TUBE (71205-057-01) June 1, 2018
0536-1256-28 0536-1256 RUGBY LABORATORIES 30 g in 1 BOX (0536-1256-28) April 30, 2020
69396-027-01 69396-027 Trifecta Pharmaceuticals USA, LLC. 1 TUBE in 1 BOX (69396-027-01) / 28 g in 1 TUBE March 15, 2017
69396-027-33 69396-027 Trifecta Pharmaceuticals USA, LLC. 3 TUBE in 1 BOX (69396-027-33) / 28 g in 1 TUBE May 15, 2025
69396-027-44 69396-027 Trifecta Pharmaceuticals USA, LLC. 4 TUBE in 1 BOX (69396-027-44) / 28 g in 1 TUBE March 15, 2024
59898-720-01 59898-720 Water-Jel Technologies 1728 PACKET in 1 CARTON (59898-720-01) / .9 g in 1 PACKET November 7, 2010
59898-720-02 59898-720 Water-Jel Technologies 144 PACKET in 1 BOX, UNIT-DOSE (59898-720-02) / .9 g in 1 PACKET November 7, 2010
59898-720-03 59898-720 Water-Jel Technologies 25 PACKET in 1 BOX, UNIT-DOSE (59898-720-03) / .9 g in 1 PACKET November 7, 2010
59898-720-36 59898-720 Water-Jel Technologies .9 g in 1 PACKET (59898-720-36) November 7, 2010
50090-0815 50090-0815 A-S Medication Solutions — June 20, 2011
50090-0845 50090-0845 A-S Medication Solutions — June 20, 2011
84387-002 84387-002 ALLIED TRADE LINK LLC — October 24, 2024
87236-000 87236-000 AlderMed Inc. — November 1, 2025
68001-477 68001-477 BluePoint Laboratories — November 24, 2020
71335-2731 71335-2731 Bryant Ranch Prepack — June 20, 2011
72162-2280 72162-2280 Bryant Ranch Prepack — June 20, 2011
59779-536 59779-536 CVS Pharmacy — June 8, 2005
0713-0280 0713-0280 Cosette Pharmaceuticals, Inc. — January 10, 1995
67777-116 67777-116 Dynarex Corporation — September 12, 2016
37808-536 37808-536 H E B — June 15, 1991
41226-880 41226-880 Kroger — November 15, 2025
30142-536 30142-536 Kroger Company — April 19, 2017
41250-844 41250-844 Meijer Distribution Inc — October 24, 2018
68071-5253 68071-5253 NuCare Pharmaceuticals,Inc. — January 10, 1995
45802-060 45802-060 Padagis Israel Pharmaceuticals Ltd — June 20, 2011
68788-4153 68788-4153 Preferred Pharmaceuticals Inc. — July 15, 2026
68788-8643 68788-8643 Preferred Pharmaceuticals Inc. — April 30, 2024
68788-9794 68788-9794 Preferred Pharmaceuticals, Inc — April 30, 2012
63187-299 63187-299 Proficient Rx LP — December 1, 2009
71205-057 71205-057 Proficient Rx LP — January 10, 1995
0536-1256 0536-1256 RUGBY LABORATORIES — April 30, 2020
69396-027 69396-027 Trifecta Pharmaceuticals USA, LLC. — March 15, 2017
59898-720 59898-720 Water-Jel Technologies — November 7, 2010

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.