Antibiotic

Product NDC: 51316-044
Requested package NDC: 51316-044-01
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: 2027-12-31
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: 2027-12-31

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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE	Universal Distribution Center LLC	78f00296-267b-44c3-a9e3-c40f122e905e	2024-05-14	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	JHK Inc dba American Safety & First Aid	26e66025-9457-42b3-9319-51302c17506e	2024-04-26	Warnings	Exact identifier application number: M004
Hydrogen Peroxide	HYDROGEN PEROXIDE	JHK Inc	1472c854-09c8-4ad8-b8a6-0235440ac26b	2024-04-26	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	JHK Inc	abae6a80-e859-47b5-8e34-d391eb854583	2024-04-26	Warnings	Exact identifier application number: M004
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	JHK Inc	0ac5d890-c262-4a30-9fd8-2de6cb0f7601	2024-04-25	Warnings	Exact identifier application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	M-star (Hubei) Health&Care Products Co., Ltd.	c6f2656e-b822-4d61-b557-dd2046dd51f5	2024-04-01	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE	CVS PHARMACY, INC	32e92acf-2e48-4933-8e08-e1df650e7d19	2024-03-15	Warnings	Exact identifier application number: M004 ndc (package): 51316-044-01 ndc (product): 51316-044 ndc11 (package): 51316004401
Major Bacitracin	BACITRACIN	Major Pharmaceuticals	13288efb-e282-68f8-e063-6294a90ae712	2024-03-08	Warnings	Exact identifier application number: M004
UniShield TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unishield	00b85d3a-322b-43c1-b022-5f6ed50c6609	2024-03-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Chain Drug Marketing Association Inc.	1277942d-753f-ab69-e063-6394a90a496a	2024-02-28	Warnings	Exact identifier application number: M004
Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Safetec of America, Inc.	ca1df4a0-844d-4b1d-b972-f2704a8ebbab	2024-02-16	Warnings	Exact identifier application number: M004
Single Antibiotic	BACITRACIN ZINC	Safetec of America, Inc.	9993c204-6e61-4da3-90ef-2b7dfa09c920	2024-02-14	Warnings	Exact identifier application number: M004
Single Antibiotic with Neomycin	NEOMYCIN SULFATE	Safetec of America	e989cf7e-f3d1-42d2-af45-fc80095b97cb	2024-02-08	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	96c41fc1-81f9-4757-abc6-867b5383ed5d	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	2c2aa8af-2adb-4f59-ac20-15818d0e28e7	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	03c05028-5a5f-4690-a836-cc1b1044ab39	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	59494d5c-dd8a-431c-8e6a-4e1151ba7460	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC	BluePoint Laboratories	c47e15bd-1062-4cca-e053-2995a90a9075	2024-01-31	Warnings	Exact identifier application number: M004
Neomycin	NEOMYCIN OINTMENT	Dynarex Corporation	0f9e087b-6e86-a3c7-e063-6394a90ac8d4	2024-01-23	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Target Corporation	050be94c-1fbb-4d84-82c6-841aac8f318e	2024-01-18	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