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 15 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neosporin Kids Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	6752f0a0-2432-4d8b-8198-74ae96a68963	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	a3e6fe2e-1b74-4f22-9c7c-a00057439690	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	32302dcd-f3f1-408b-ae5f-e7d8b666f68f	2024-11-13	Warnings	Exact identifier application number: M004
NEOSPORIN Plus BURN RELIEF	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	3caa7fd1-bd66-427e-a6c0-1b137b205089	2024-11-13	Warnings	Exact identifier application number: M004
Simply Neosporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	68bfecea-095f-4d3f-b077-d86e1b9f1faa	2024-11-13	Warnings	Exact identifier application number: M004
Triple Antibiotic and Burn Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	fdc510b8-f3ad-4bd6-a8d0-1b81e9f30e13	2024-11-13	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	ALLIED TRADE LINK LLC	253e5b98-c64f-3226-e063-6294a90a9352	2024-11-12	Warnings	Exact identifier application number: M004
TRIPLET ANTIBIOTIC	TRIPLET ANTIBIOTIC	ALLIED TRADE LINK LLC	26bd5ba4-264b-2a28-e063-6394a90ada80	2024-11-12	Warnings	Exact identifier application number: M004
basic care first aid antibiotic and burn relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Amazon.com Services LLC	0df4c44d-6912-4db9-a703-a82da4c8ae76	2024-11-11	Warnings	Exact identifier application number: M004
SUPER SENSITIVE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	7d4a5b21-82d2-4904-9577-4a9b2579076e	2024-11-08	Warnings	Exact identifier application number: M004
dg health triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	4c97dada-966f-4de8-b5d9-e939cb456aea	2024-11-06	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	de07139e-ece9-424b-8468-f5ed4bbb2b2b	2024-11-06	Warnings	Exact identifier application number: M004
good sense triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	e9e913d8-8ec8-4465-ad3a-b524f6710a0f	2024-11-06	Warnings	Exact identifier application number: M004
EUCALYPTUS EASE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	09d77591-9472-4771-9090-3390bddf788a	2024-11-06	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	A-S Medication Solutions	e115d413-e41c-4e43-8184-493d64dfcd9f	2024-11-06	Warnings	Exact identifier application number: M004
LEMON MYRTLE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	f341b24c-9466-42f4-98fe-d1a122591915	2024-11-06	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	00747e3a-389c-46bc-b6b9-9b3d1d98dbcf	2024-11-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Safeway	46db4b66-85a2-47fc-a643-df6477e2ddff	2024-11-06	Warnings	Exact identifier application number: M004
CALMING HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	ffcbe34d-3c53-47f9-9e4a-b5448afbbd5d	2024-11-05	Warnings	Exact identifier application number: M004
Antibiotic, Pain and Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	CVS Pharmacy	8bb6cb64-103f-454a-95ad-c2c56b9cf71a	2024-11-05	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