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 3 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medi First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	545fa5b6-781c-18ae-e063-6294a90a2f0d	2026-06-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC ORIGINAL STRENGTH	Aldermed Inc.	19eace87-b505-4be6-93b3-db5323e34216	2026-06-12	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	AlderMed Inc.	3f0eb4a0-f7bf-45f7-8885-92c65a4bd899	2026-06-08	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	Aldermed Inc.	7f4bff4f-588d-4e45-8aa3-f95b4d746f25	2026-06-08	Warnings	Exact identifier application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Aldermed Inc.	5bfc7776-1030-48ba-9df4-897c4984c9e6	2026-06-08	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4545c043-8e8e-4288-b4d8-e6ec9d72f979	2026-06-04	Warnings	Exact identifier application number: M004
First Aid Kit, Orazen Inc	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Orazen Inc	525bcb89-af5b-8652-e063-6294a90a41a6	2026-06-03	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Sun Pharmaceutical Industries, Inc.	d77239e6-5e81-439a-b0cd-f8be59169442	2026-06-02	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	HyVee Inc	3ac9f0fc-e08c-49d9-9079-3ba0393c612b	2026-06-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	HyVee Inc	69a4b642-b7ec-43cc-aa57-6858da0b3d63	2026-06-02	Warnings	Exact identifier application number: M004
Careland Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Planet (Anhui) Pharmaceutical Co., Ltd.	0e64179d-fce2-48fc-833e-ce43a54b987c	2026-05-31	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Fanjian Medical Product Co.,Ltd	f44ab989-c618-1831-e053-2995a90adc8e	2026-05-28	Warnings	Exact identifier application number: M004
Vitastem-tetracycline hydrochloride	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	7ffe82a4-864b-48c7-9307-d262f20ca01e	2026-05-26	Warnings	Exact identifier application number: M004
Viaderma Vitastem First Aid Topical Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	6eb04a76-7995-4df6-9c9b-dd450537e538	2026-05-26	Warnings	Exact identifier application number: M004
Medi-First Bacitracin Zinc	BACITRACIN	Unifirst First Aid Corporation	54609a4f-0fe9-b750-e063-6394a90ae9ce	2026-05-26	Warnings	Exact identifier application number: M004
Hand San	ALCOHOL	Rochester Midland Corporation	2d89982d-d1fd-4a98-8b44-c2ae3545be58	2026-05-14	Warnings	Exact identifier application number: M004
first aid antibiotic	BACITRACIN	HyVee Inc	97c87111-260a-48d0-92cd-e22f55a48c7d	2026-05-12	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Walgreens Co.	32df5cca-77bc-45d2-b1f6-2cfdfc371ea9	2026-05-12	Warnings	Exact identifier application number: M004
ANTIBIOTIC Maximum Strength	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Walgreens Co.	653c88bf-5b7d-45be-a131-d59990573e9c	2026-05-12	Warnings	Exact identifier application number: M004
Fresh Start	CHLOROXYLENOL	Pro Chem, Inc.	dd1708d8-0bb2-c96a-e053-2995a90a5b86	2026-05-11	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