American Safety and First Aid Triple Antibiotic

Product NDC: 71927-016
11-digit product format: 719270016
Labeler code: 71927
Product ID: 71927-016_5aec55a6-0ab6-6439-e063-6294a90ab438
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: 2026-09-05
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: 2027-12-31
Current FDA listing: Yes

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: American Safety and First Aid Triple Antibiotic
Listing expiration: 2027-12-31

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
71927-016-02	2024-01-30	C162847	48780-1	1030e365-457c-111a-e063-dadaa90a10e2	71927-016-01, 02, 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 8 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GASCO ANTIBACTERIAL	BENZALKONIUM CHLORIDE	GASCO INDUSTRIAL CORP	411ffefe-16e5-a2e0-e063-6394a90a0cd4	2025-10-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	4124e9e2-397f-8921-e063-6394a90a5ffe	2025-10-14	Warnings	Exact identifier application number: M004
Antibiotic	NEOMYCIN SULFATE	Total Resources International	0725364b-b243-4891-af2f-a6049366d038	2025-10-10	Warnings	Exact identifier application number: M004
MediChoice Bacitracin	BACITRACIN	O&M HALYARD, INC.	78079b94-c6fc-4529-aaad-8186924ecba5	2025-10-09	Warnings	Exact identifier application number: M004
MediChoice Triple Antibiotic	BACITRACIN	O&M HALYARD, INC.	8369f399-6f64-4441-be72-1f16c7306c0a	2025-10-09	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Medline Industries, LP	301ebb9a-033b-4f04-99ff-571e921924ca	2025-10-09	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	Medline Industries, LP	f8282204-f9b9-486f-b18b-dc5ba85cce10	2025-10-09	Warnings	Exact identifier application number: M004
TheraCare Triple Antibiotic Pain Relief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Veridian Healthcare	faf73908-324f-27f5-e053-6394a90aa06e	2025-10-02	Warnings	Exact identifier application number: M004
Viaderma Care First Aid	BACITRACIN ZINC	ViaDerma Distribution, Inc.	dabb7ce8-3284-4dfc-bc6e-38a691be43c1	2025-10-02	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC POLYMYXIN B SULFATE	Encube Ethicals, Inc.	8f00b059-6729-4fae-8e8c-e14fe8838c59	2025-09-30	Warnings	Exact identifier application number: M004
Xpect Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Cintas Corporation	39355db3-24d7-485f-9ce0-f0e466e96593	2025-09-26	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCL	Encube Ethicals, Inc.	dfea6b2e-cd76-439d-a3da-64e2d8717163	2025-09-25	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Encube Ethicals, Inc.	2e985ad0-aa50-4c6b-b0af-1d61489a9fda	2025-09-25	Warnings	Exact identifier application number: M004
Medi-First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	f2f0a1da-3e33-3c1a-e053-2a95a90a12b1	2025-09-09	Warnings	Exact identifier application number: M004
Ecolab Triple Antibiotic	BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Ecolabs Food Safety Specialties, Inc.	4aef8f98-db76-07f2-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	d265f094-e654-4c68-9215-b5d061af885d	2025-09-08	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	d7c1a10e-c38d-4ae8-9a27-c07c2208ca84	2025-09-08	Warnings	Exact identifier application number: M004
Thompson Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Thompson	f883c4cb-c32c-76e3-e053-6294a90aa4fc	2025-09-08	Warnings	Exact identifier application number: M004
Thompson Triple Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	Thompson	de9489de-e677-2bd3-e053-2a95a90acfb4	2025-09-08	Warnings	Exact identifier application number: M004
BACITRACIN ZINC	FIRST AID ANTIBIOTIC	Encube Ethicals, Inc.	613cbed4-9790-4e6b-a61b-b7b7a8ee59c9	2025-09-04	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	2026-09-05	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	2026-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
71927-016-01, 02, American Safety & First Aid Triple Antibiotic	Orazen Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-09-07	HUMAN OTC DRUG LABEL	3
71927-016-01, 03, American Safety & First Aid Triple Antibiotic	Orazen Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-09-07	HUMAN OTC DRUG LABEL	3