Schein Bacitracin

Product NDC: 0404-0400
11-digit product format: 004040400
Labeler code: 0404
Product ID: 0404-0400_f1634ac6-dd80-1580-e053-2995a90a842a
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN ZINC
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Henry Schein, Inc.
Application: M004
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-12-04
Marketing end: 2024-01-01
Substance: BACITRACIN ZINC
Active strength: 500 [iU]/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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0404-0400		D	Discontinued by firm	2026-10-15
excluded package	package	0404-0400	0404-0400-47	D	Discontinued by firm	2026-10-15
excluded package	package	0404-0400	0404-0400-48	D	Discontinued by firm	2026-10-15

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 · 36 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	0404-0400-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0404-0400-47	`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	0404-0400-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0404-0400-47	`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	0404-0400-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0404-0400-47	`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	0404-0400-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0404-0400-47	`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	0404-0400-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0404-0400-47	`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	0404-0400-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0404-0400-47	`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	0404-0400-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0404-0400-47	`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	0404-0400-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0404-0400-47	`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	0404-0400-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0404-0400-47	`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	0404-0400-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0404-0400-47	`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	0404-0400-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0404-0400-47	`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	0404-0400-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0404-0400-47	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	SCHEIN BACITRACIN (BACITRACIN ZINC) OINTMENT [HENRY SCHEIN, INC.]	5
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	SCHEIN BACITRACIN (BACITRACIN ZINC) OINTMENT [HENRY SCHEIN, INC.]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SCHEIN BACITRACIN (BACITRACIN ZINC) OINTMENT [HENRY SCHEIN, INC.]	5

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 12 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Front Pharmaceutical PLC	3244d91e-6c6b-a351-e063-6294a90aa02d	2025-04-08	Warnings	Exact identifier application number: M004
Walgreens Advanced Wound Hydrogel	ALLANTOIN, BENZETHONIUM CHLORIDE	WALGREEN COMPANY	25c6ada8-4a16-0896-e063-6294a90a0fdb	2025-04-08	Warnings	Exact identifier application number: M004
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	13c1f2df-ba52-45e0-8868-a7518e9cdb55	2025-04-07	Warnings	Exact identifier application number: M004
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	93a6e02e-9f4b-4821-afa2-2029769f3088	2025-04-07	Warnings	Exact identifier application number: M004
burn gel 01	MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3227bdc9-9323-68eb-e063-6294a90a29d2	2025-04-06	Warnings	Exact identifier application number: M004
Vitastem ULTRA	BACITRACIN ZINC	ViaDerma Distribution, Inc	fd96cc09-8522-44a5-b034-0d30e532410d	2025-04-03	Warnings	Exact identifier application number: M004
Vitastem Ultra First Aid Antibiotic	BACITRACIN ZINC	Viaderma Distribution Inc	e6986bf9-22ea-4484-a709-27bc91c9058d	2025-03-18	Warnings	Exact identifier application number: M004
Redicare Triple Antibiotic First Aid	TRIPLE ANTIBIOTIC FIRST AID OINTMENT	Redicare LLC	9468979d-446e-e4be-e053-2995a90a3f21	2025-03-05	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	0ad21575-0e2d-24c2-e063-6394a90a616e	2025-02-21	Warnings	Exact identifier application number: M004
The Life Safety Pro Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	64a7331f-98a6-4052-85b9-695c83b3bd16	2025-02-19	Warnings	Exact identifier application number: M004
Vitastem	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	a6630858-7038-425f-8a75-bb25f36a0dbe	2025-02-18	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	Sheffield Pharmaceuticals LLC	1aa95046-c1f7-4fc7-acac-839065d998f6	2025-02-17	Warnings	Exact identifier application number: M004
Equate	BACITRACIN ZINC ANTIBIOTIC OINTMENT	Walmart Inc.	20908780-8803-4e19-e063-6394a90aab87	2025-02-01	Warnings	Exact identifier application number: M004
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	0961b097-ba41-40c2-aaec-dd291841bf09	2025-01-30	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Welly Health PBC	9446375d-4bb4-4bb1-bdc2-c18e995bfe26	2025-01-29	Warnings	Exact identifier application number: M004
FAK Care4 Bus and School Yellow ORM D	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	2025-01-22	Warnings	Exact identifier application number: M004
Members Mark Alcohol Prep Pads, Sterile	ISOPROPYL ALCOHOL	Sam's Club West Inc.	13001877-ae90-40be-899d-fb38f3a38b12	2025-01-22	Warnings	Exact identifier application number: M004
Equate Antibiotic Plus Pain, Itch, Scar Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	WalMart	2b743271-4f58-4ba1-a04c-560f7f8a547e	2025-01-16	Warnings	Exact identifier application number: M004
Equate Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	WalMart	e08b427f-d070-4521-ad3c-faf295531791	2025-01-16	Warnings	Exact identifier application number: M004
NATUREPLEX ANTIBIOTIC	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Natureplex LLC	86ea3452-c810-4c9a-9f52-bcb0688020f9	2025-01-15	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-0400-47	00404040047	144 PACKET in 1 CARTON (0404-0400-47) > .9 g in 1 PACKET (0404-0400-09)	144 packet	2011-12-04	0000-00-00	No	No	Current
0404-0400-48	00404040048	1 TUBE in 1 CARTON (0404-0400-48) > 28 g in 1 TUBE (0404-0400-28)	1 tube	2011-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Henry Schein, Inc. \| ULTRAtab Laboratories, Inc. \| Ultra Seal Corporation	2023-01-03	HUMAN OTC DRUG LABEL	9