Bacitracin Zinc

Product NDC: 0472-1105
11-digit product format: 004721105
Labeler code: 0472
Product ID: 0472-1105_5de78561-171c-470d-8990-3d83980953ce
Type: HUMAN OTC DRUG
Nonproprietary name: bacitracin zinc
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1997-06-01
Marketing end: 2023-01-31
Substance: BACITRACIN ZINC
Active strength: 500 [USP'U]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0472-1105		D	Discontinued by firm	2026-08-10
excluded package	package	0472-1105	0472-1105-26	D	Discontinued by firm	2026-08-10
excluded package	package	0472-1105	0472-1105-34	D	Discontinued by firm	2026-08-10
excluded package	package	0472-1105	0472-1105-56	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0472-1105-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0472-1105-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0472-1105-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0472-1105-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0472-1105-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0472-1105-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0472-1105-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0472-1105-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0472-1105-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0472-1105-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0472-1105-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0472-1105-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0472-1105-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0472-1105-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0472-1105-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0472-1105-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0472-1105-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0472-1105-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0472-1105-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0472-1105-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0472-1105-56	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0472-1105-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0472-1105-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0472-1105-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0472-1105-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0472-1105-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0472-1105-56	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0472-1105-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0472-1105-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0472-1105-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0472-1105-26	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0472-1105-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0472-1105-56	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0472-1105-26	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0472-1105-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0472-1105-56	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-1105-34	GM - Gram	0472-1105	db8fcb8a-f27b-4101-8155-ab75e3d44fec	1	2013-02-13
0472-1105-56	GM - Gram	0472-1105	2db5cf61-42cf-49e4-9bb3-9b667753b06a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	BACITRACIN ZINC OINTMENT [ACTAVIS PHARMA, INC.]	4
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	BACITRACIN ZINC OINTMENT [ACTAVIS PHARMA, INC.]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BACITRACIN ZINC OINTMENT [ACTAVIS PHARMA, INC.]	4
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BACITRACIN ZINC OINTMENT [AIDAREX PHARMACEUTICALS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1366116	bacitracin zinc 500 UNT/GM Topical Ointment	PSN	aee808f9-e759-4129-9661-29c2a3bd9a30	1
1366116	bacitracin zinc 0.5 UNT/MG Topical Ointment	SCD	aee808f9-e759-4129-9661-29c2a3bd9a30	1
1366116	bacitracin zinc 500 UNT per GM Topical Ointment	SY	aee808f9-e759-4129-9661-29c2a3bd9a30	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-1105-26	00472110526	1 TUBE in 1 CARTON (0472-1105-26) > 28 g in 1 TUBE	1 tube	1997-06-01	2023-01-31	No	No	Current
0472-1105-34	00472110534	1 TUBE in 1 CARTON (0472-1105-34) > 14 g in 1 TUBE	1 tube	1997-06-01	2023-01-31	No	No	Current
0472-1105-56	00472110556	1 TUBE in 1 CARTON (0472-1105-56) > 28 g in 1 TUBE	1 tube	1997-06-01	2023-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bacitracin Zinc Ointment_OTC	Actavis Pharma, Inc.	2022-09-23	HUMAN OTC DRUG LABEL	11
Bacitracin Zinc Oint USP Actavis part333B	A-S Medication Solutions	2018-08-03	HUMAN OTC DRUG LABEL	5
Bacitracin Zinc Oint USP Actavis part333B	A-S Medication Solutions	2018-02-23	HUMAN OTC DRUG LABEL	4
Bacitracin Zinc Ointment, USP	Aidarex Pharmaceuticals LLC	2012-09-10	HUMAN OTC DRUG LABEL	1