American Safety and First Aid Triple Antibiotic

Product NDC: 71927-016
11-digit product format: 719270016
Labeler code: 71927
Product ID: 71927-016_0effc169-28e6-9eb0-e063-6394a90a432a
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Orazen Inc
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-10-17
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400; .0035; 5000 [USP'U]/g; g/g; [USP'U]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71927-016		I	Inactivated by FDA		2026-08-07
excluded package	package	71927-016	71927-016-02	I	Inactivated by FDA		2026-08-07

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 · 30 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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`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	71927-016-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71927-016-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71927-016-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71927-016-02	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: American Safety and First Aid Triple Antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [USP'U]/g
NEOMYCIN SULFATE	.0035 g/g
POLYMYXIN B SULFATE	5000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204602	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eb0df2da-1688-c477-e053-2995a90a74a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71927-016-02	2024-01-30	C162847	48780-1	1030e365-457c-111a-e063-dadaa90a10e2	American Safety & First Aid Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71927-016-01	American Safety and First Aid Triple Antibiotic	0.5 g in 1 POUCH	OINTMENT	0.5	2
71927-016-03	American Safety and First Aid Triple Antibiotic	144 in 1 BOX	OINTMENT	144	2
71927-016-01	American Safety and First Aid Triple Antibiotic	0.5 g in 1 POUCH	OINTMENT	0.5	1
71927-016-02	American Safety and First Aid Triple Antibiotic	25 in 1 BOX	OINTMENT	25	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71927-016	AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]	2	Current NDC, Legacy NDC, 2 package rows	20240116_eb0df2da-1688-c477-e053-2995a90a74a2.zip
71927-016	AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]	1	Current NDC, Legacy NDC, 2 package rows	20221018_eb0d108f-42bf-3364-e053-2a95a90a4542.zip

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 1 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	Vive Health LLC	236c62bf-3de0-0b3e-e063-6394a90ad6c6	2026-07-21	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Vive Health LLC	21b38b00-1e64-83d8-e063-6294a90a07bd	2026-07-21	Warnings	Exact identifier application number: M004
DERMFREE Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a5603-3478-5f7a-e063-6294a90acc40	2026-07-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN ZINC	Preferred Pharmaceuticals Inc.	e094566b-3b80-45ac-be73-54c798bbb763	2026-07-15	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	L. Perrigo Company	3eadd35c-3df2-4e46-b76d-a6e537895917	2026-07-10	Warnings	Exact identifier application number: M004
Ever Ready First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	ee1ad6d7-e9c1-2b20-e053-2995a90a3366	2026-07-03	Warnings	Exact identifier application number: M004
Single Antibiotic with bacitracin	BACITRACIN ZINC	Safetec of America	4ae9a105-e3f9-4015-8844-085e0b34cdb6	2026-06-25	Warnings	Exact identifier application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)	BENZALKONIUM CHLORIDE	Eleeo Brands LLC	551baf59-39b9-e994-e063-6294a90a65e6	2026-06-25	Warnings	Exact identifier application number: M004
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	eb0df2da-1688-c477-e053-2995a90a74a2	2
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	eb0df2da-1688-c477-e053-2995a90a74a2	2
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	eb0df2da-1688-c477-e053-2995a90a74a2	2
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	eb0d108f-42bf-3364-e053-2a95a90a4542	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	eb0d108f-42bf-3364-e053-2a95a90a4542	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	eb0d108f-42bf-3364-e053-2a95a90a4542	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71927-016-01	71927001601	0.5 g in 1 POUCH	0.5 g					Historical
71927-016-02	71927001602	25 POUCH in 1 BOX (71927-016-02) > .5 g in 1 POUCH (71927-016-01)	25 pouch	2022-10-17	0000-00-00	No	No	Current
71927-016-03	71927001603	144 POUCH in 1 BOX (71927-016-03) / .5 g in 1 POUCH (71927-016-01)	144 pouch	2022-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
71927-016 American Safety & First Aid Triple Antibiotic	Orazen Inc	2024-01-15	HUMAN OTC DRUG LABEL	2
American Safety & First Aid Triple Antibiotic	Orazen Inc	2022-10-15	HUMAN OTC DRUG LABEL	1