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

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 1 of 22 · 437 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	NuCare Pharmaceutical, Inc.	5b14499e-e45c-7c05-e063-6294a90a1cc2	2026-09-09	Warnings	Exact identifier application number: M004
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0df2da-1688-c477-e053-2995a90a74a2	2026-09-07	Warnings	Exact identifier application number: M004 ndc (product): 71927-016
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0d108f-42bf-3364-e053-2a95a90a4542	2026-09-07	Warnings	Exact identifier application number: M004 ndc (product): 71927-016
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4d0a4-b90c-99b0-e053-2995a90ab423	2026-09-04	Warnings	Exact identifier application number: M004
Lil Drug Store Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	e6e5263b-328f-4775-9fac-34302f050ce0	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e42c5c-e080-4efb-e053-2a95a90af52e	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4854a-ee01-df72-e053-2995a90aa8ea	2026-09-04	Warnings	Exact identifier application number: M004
Circle K Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a	2026-09-04	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Walgreen Company	b982091a-5aa0-4bbc-bb1d-08016f6d0a70	2026-09-03	Warnings	Exact identifier application number: M004
SurviveX Triple Antibiotic	TRIPLE ANTIBIOTIC	Nantong Health & Beyond Hygienic Products Inc.	5a7cb52d-a60c-b947-e063-6394a90afb0d	2026-09-02	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Walgreen Company	4f3cfe39-2df8-48b4-954d-5997217c92ba	2026-08-31	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	217aa2b8-94f5-468a-99b4-52824a77b573	2026-08-28	Warnings	Exact identifier application number: M004
OP Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Yiwu Ori-Power Medtech Co., Ltd.	03f3cce9-7e9f-90a6-e063-6294a90a660b	2026-08-28	Warnings	Exact identifier application number: M004
Alcare Extra Hand Sanitizer	ALCOHOL	SC Johnson Professional USA Inc.	5dc007a2-61fa-4115-a82c-1aa489a6bd39	2026-08-27	Warnings	Exact identifier application number: M004
InstantFoam Complete PURE	ALCOHOL	SC Johnson Professional USA Inc.	398ca23c-7202-4670-be14-9829675f7174	2026-08-27	Warnings	Exact identifier application number: M004
Be Smart Get Prepared Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Total Resources International, Inc	57ed1a03-7e1b-4eb4-8001-dfd118805edc	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC	Gentell LLC	59c5a363-6d79-d07e-e063-6294a90a8753	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B	Gentell LLC	597cb2f0-ff05-a1ab-e063-6294a90acda9	2026-08-20	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Shield Line LLC	5ba3e703-7873-4724-a0bf-bb22d8a25748	2026-08-18	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC	Shield Line LLC	e6a6fb0f-5ab7-4647-84a0-7b9948eed303	2026-08-18	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
71927-016-01, 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