Antibiotic

Product NDC: 51316-044
11-digit product format: 513160044
Labeler code: 51316
Product ID: 51316-044_50187929-7372-4b3d-939d-d13be4dc4b51
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Polymyxin B Sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: CVS PHARMACY, INC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-25
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 500; 10000 [iU]/g; [iU]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	500 [iU]/g
POLYMYXIN B SULFATE	10000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308512	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
32e92acf-2e48-4933-8e08-e1df650e7d19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-044-01	Antibiotic	28 g in 1 TUBE	OINTMENT	28		3
51316-044-01	Antibiotic	1 in 1 CARTON	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-044	ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [CVS PHARMACY, INC]	3	Current NDC, Legacy NDC, 2 package rows	20240316_32e92acf-2e48-4933-8e08-e1df650e7d19.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 18 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Padagis Israel Pharmaceuticals Ltd	28fff253-ddd4-4669-aa90-b4caf48c905f	2024-09-22	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Safeway	044aff98-f398-40f5-8c18-2751b4ab4384	2024-09-18	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	American Sales Company	09a0b0b9-1806-4ff9-80fa-448dabbf2cc7	2024-09-18	Warnings	Exact identifier application number: M004
equaline first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	United Natural Foods, Inc. dba UNFI	022e009e-0192-4089-86f3-4d63448e0f88	2024-09-18	Warnings	Exact identifier application number: M004
DG Health Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Dolgencorp, LLC	1694f4ee-1065-4b13-b642-b8437f473541	2024-09-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Kroger Company	c531bac4-ab15-4fde-99a7-19e20ce10387	2024-09-17	Warnings	Exact identifier application number: M004
EQUATE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Wal-Mart Stores Inc	fa35f446-6a58-4d8c-859e-89cd631a9e8f	2024-09-17	Warnings	Exact identifier application number: M004
basic care first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Amazon.com Services LLC	c159b18d-0d6e-409f-8b2b-e8f28cd85633	2024-09-17	Warnings	Exact identifier application number: M004
Major Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFAT	Major Pharmaceuticals	a6cc3fbc-6302-4033-e053-2a95a90a19f0	2024-09-11	Warnings	Exact identifier application number: M004
Leader Triple antibiotic	BACITRACIN,NEOMYCIN,POLYMXIN	Cardinal Health 110 dba LEADER	2175e00a-bf85-3377-e063-6394a90a916f	2024-09-06	Warnings	Exact identifier application number: M004
Members Mark Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Sam's West Inc	200f4020-7699-4a9e-8fab-2d3df9e76836	2024-09-05	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	BACITRACIN ZINC POLYMIXIN B SULFATE	Cardinal Health 110 dba LEADER	20d7624f-cafa-25e1-e063-6394a90a4439	2024-08-29	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Meijer Distribution Inc	edcb423e-b5c2-4e26-8f7f-9b9ee575042c	2024-08-19	Warnings	Exact identifier application number: M004
Major Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	562dfc9f-1897-330a-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Wildeman Business Group	1f96450a-3bda-1f0a-e063-6294a90a514f	2024-08-13	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Provision Medical	bbf4b99c-9738-4855-82a6-f4e213924ec9	2024-08-09	Warnings	Exact identifier application number: M004
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	4ac5177d-bb67-45e6-adcf-44f0821746bd	2024-08-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Padagis Israel Pharmaceuticals Ltd	bebbedf6-dd65-47a4-aa3e-ad197b3e05a1	2024-07-31	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	PSN	32e92acf-2e48-4933-8e08-e1df650e7d19	3
308512	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Ointment	SCD	32e92acf-2e48-4933-8e08-e1df650e7d19	3
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	SY	32e92acf-2e48-4933-8e08-e1df650e7d19	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-044-01	51316004401	1 TUBE in 1 CARTON (51316-044-01) / 28 g in 1 TUBE	1 tube	2022-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)	CVS PHARMACY, INC	2024-03-15	HUMAN OTC DRUG LABEL	3