OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Antibiotic

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate · 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
Antibiotic
Generic name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
CVS PHARMACY, INC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
9
NDC product codes
7
Packages
9
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 [USP'U]/g 1648110 View
Bacitracin Zinc 400 [USP'U]/g 204602 View
Bacitracin Zinc 500 [iU]/g 204602 View
Bacitracin Zinc 6 mg/mL 204602 View
Neomycin Sulfate 3.5 mg/g 204602 View
Neomycin Sulfate 3.5 mg/mL 204602 View
Polymyxin B Sulfate .77 mg/mL 204602 View
Polymyxin B Sulfate 10000 [iU]/g 204602 View
Polymyxin B Sulfate 5000 [USP'U]/g 204602 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
16

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
Aminoglycoside Antibacterial [EPC] EPC All 66 members
Aminoglycosides [CS] CS All 66 members
Decreased Cell Wall Synthesis & Repair [PE] PE All 41 members
Polymyxin-class Antibacterial [EPC] EPC All 55 members
Polymyxins [CS] CS All 55 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 20250129). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250129 HUMAN OTC DRUG · 20241016 HUMAN OTC DRUG · 20240923

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 Antibiotics

Dosage and Administration

openFDA Drug Labeling

Directions • 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

Warnings

openFDA Drug Labeling

Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use internally in eyes over large areas of the body or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if you are allergic to any of the ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use 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 • rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each gram) Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate

Adverse event reports

Source: openFDA FAERS
4,875
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: POLYMYXIN B SULFATE. 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
51316-044-01 51316-044 CVS PHARMACY, INC 1 TUBE in 1 CARTON (51316-044-01) / 28 g in 1 TUBE February 25, 2022
69842-199-16 69842-199 CVS Pharmacy 1 TUBE in 1 CARTON (69842-199-16) / 56 g in 1 TUBE August 4, 2016
69842-199-58 69842-199 CVS Pharmacy 1 TUBE in 1 CARTON (69842-199-58) / 14 g in 1 TUBE August 4, 2016
69842-199-64 69842-199 CVS Pharmacy 1 TUBE in 1 CARTON (69842-199-64) / 28 g in 1 TUBE August 4, 2016
36800-536-64 36800-536 Topco Associates LLC 1 TUBE in 1 CARTON (36800-536-64) / 28 g in 1 TUBE April 3, 2020
55550-730-21 55550-730 Total Resources International .9 g in 1 POUCH (55550-730-21) October 7, 2019
0363-0018-56 0363-0018 Walgreens 1 TUBE in 1 CARTON (0363-0018-56) / 28 g in 1 TUBE June 16, 1998
0363-1331-01 0363-1331 Walgreens Co. 1 TUBE in 1 CARTON (0363-1331-01) / 28 g in 1 TUBE January 29, 2025
72663-560-34 72663-560 Welly Health PBC .5 mL in 1 POUCH (72663-560-34) February 25, 2019
51316-044 51316-044 CVS PHARMACY, INC — February 25, 2022
69842-199 69842-199 CVS Pharmacy — August 4, 2016
36800-536 36800-536 Topco Associates LLC — April 3, 2020
55550-730 55550-730 Total Resources International — October 7, 2019
0363-0018 0363-0018 Walgreens — June 16, 1998
0363-1331 0363-1331 Walgreens Co. — January 29, 2025
72663-560 72663-560 Welly Health PBC — February 25, 2019

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.