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	2026-10-12
excluded package	package	0404-0400	0404-0400-47	D	Discontinued by firm	2026-10-12
excluded package	package	0404-0400	0404-0400-48	D	Discontinued by firm	2026-10-12

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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Water-Jel Neomycin Antibiotic	FIRST AID OINTMENT	Water-Jel Technologies	abea91a2-4453-406d-a7ed-3ffc19ef521a	2025-12-31	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic and Pain	PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	FSA Store Inc. (Caring Mills)	3c5b6909-6b30-5256-e063-6294a90a9096	2025-12-29	Warnings	Exact identifier application number: M004
Caring Mills Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	fbd11419-4513-10d7-e053-6394a90ac82b	2025-12-27	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Veridian Healthcare	8cd0cd64-fe62-4225-8986-5e8641dd6df2	2025-12-22	Warnings	Exact identifier application number: M004
PS-2261 Triple Antibiotic, 0.5g	PS-2261 TRIPLE ANTIBIOTIC, 0.5G	ProStat First Aid LLC	0072f8de-fc06-d529-e063-6294a90a08db	2025-12-15	Warnings	Exact identifier application number: M004
PS - 2895 Triple Antibiotic , 0.5g	PS - 2895 TRIPLE ANTIBIOTIC , 0.5G	Prostat First Aid LLC	0050de33-914b-f76d-e063-6394a90a7fab	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	ProStat First Aid	f76d7d18-0fa1-d943-e053-6294a90ac20a	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	Front Line Safety	0f509f96-a083-37d1-e063-6394a90a622c	2025-12-15	Warnings	Exact identifier application number: M004
ElixirTripleGuard Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	ELIXIR HEALTHCARE USA, LLC.	43edfb80-4d50-9362-e063-6394a90a2199	2025-12-13	Warnings	Exact identifier application number: M004
El Valle Decolorized Iodine	ALCOHOL	Pharmadel LLC	fd7a227b-536c-b3f7-e053-6394a90a4158	2025-12-04	Warnings	Exact identifier application number: M004
Vitastem First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	3970ac49-ab0f-4492-ba61-95a12faed500	2025-12-02	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Fourstar Group USA, Inc	2f916502-4daf-4cb9-a638-f37bb96c8077	2025-12-02	Warnings	Exact identifier application number: M004
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	ea16e1de-0100-456b-abe6-d33de78221da	2025-12-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC OINTMENT	Lil' Drug Store Products, Inc.	44e5107e-832a-2ce6-e063-6294a90a711d	2025-12-01	Warnings	Exact identifier application number: M004
Viaderma Care First Aid Antibiotic	BACITRACIN ZINC	VIADERMA DISTRIBUTION INC	0f36f396-e479-486c-b047-2760477609e2	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	New World Imports, Inc	1982b664-e8fd-4030-aa89-f7543e1b487b	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	New World Imports, Inc	9c2d417e-6fec-42f4-9f0c-2ec79de9342d	2025-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	5b0249c0-c196-4d3c-973f-49bd2d3d4a75	2025-12-01	Warnings	Exact identifier application number: M004
Neosporin Plus Lidocaine	BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE	Kenvue Brands LLC	e450b6a1-a8da-e5db-e053-2995a90a0ef0	2025-11-24	Warnings	Exact identifier application number: M004
ElixirZincoCare	ZINC OXIDE 20%	ELIXIR HEALTHCARE USA, LLC.	bac18496-3b76-4faf-abde-968d79b718d8	2025-11-22	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