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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FifthPulse Hydrocortisone 4oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fb29c8-6a28-e87e-e063-6294a90a78da	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Fred's, Inc.	41ee7a50-d36b-4214-b6f8-44f47ab44a84	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Lidl US, LLC	98389314-c2cf-4510-ab3d-41c4c4720019	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B	Publix Super Markets Inc	72bdb96c-af93-4a9b-93d9-81a94b6ff756	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	The Great Atlantic & Pacific Tea Company	7e7a0b4c-67a9-42f3-aacd-2606fde25090	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Topco Associates LLC	55a8a52c-4d03-417d-9283-406f6879bcb5	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	FRED'S, INC.	a44db5d1-7a74-44aa-9aa7-6247e771aaf2	2025-07-15	Warnings	Exact identifier application number: M004
Shopko Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Shopko Stores Operating Co., LLC	5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa	2025-07-15	Warnings	Exact identifier application number: M004
sunmark triple antibiotic plus pain relief	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	941a6a71-e898-4af3-989a-6d3aa3224338	2025-07-15	Warnings	Exact identifier application number: M004
TopCare Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	0fc0dbc6-ca1d-42be-8016-68e64f119706	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Walgreen Company	e2b7fc5b-c796-4ed1-aea7-4c810df250d5	2025-07-15	Warnings	Exact identifier application number: M004
Publix antibiotic plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Publix Super Markets Inc	d0193bf1-a257-490e-a058-5e6a514981da	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	The Great Atlantic & Pacific Tea Company	7d3435ad-7d73-4db6-8019-3040b3dadfa9	2025-07-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Wal-Mart Stores, Inc.	f5199476-1ce2-4a82-9685-40d78b7a8935	2025-07-14	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	STRATEGIC SOURCING SERVICES LLC	38414fff-8dad-44d0-9dfa-f89a63ef9b44	2025-07-14	Warnings	Exact identifier application number: M004
sunmark double antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Strategic Sourcing Services LLC	2868de5c-4894-45ee-9647-9acd3bde7cfc	2025-07-14	Warnings	Exact identifier application number: M004
Live Better Bacitracin Zinc	BACITRACIN ZINC	The Great Atlantic & Pacific Tea Company	6915940c-2eae-445c-ba58-e39d221e9d3d	2025-07-11	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	STRATEGIC SOURCING SERVICES LLC	4594948d-1f25-4d3c-a615-9e6edda05a10	2025-07-11	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Bacitracin Zinc	BACITRACIN ZINC	AmerisourceBergen	3fb302b5-7273-412c-a2ba-b76183e3f179	2025-07-11	Warnings	Exact identifier application number: M004
TopCare Bacitracin Zinc	BACITRACIN ZINC	Topco Associates LLC	5b59e26d-cc25-49a6-ac8b-f79398e18f2d	2025-07-07	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