Major Triple Antibiotic

Product NDC: 0904-8805
11-digit product format: 009048805
Labeler code: 0904
Product ID: 0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Neomycin, Polymyxin B Sulfat
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-20
Substance: NEOMYCIN SULFATE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 3.5; 400; 5000 mg/g; [USP'U]/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

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: Major Triple Antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g
BACITRACIN ZINC	400 [USP'U]/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
057Y626693	Internal UNII lookup
89Y4M234ES	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
a6cc3fbc-6302-4033-e053-2a95a90a19f0	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-8805-31	Major Triple Antibiotic	28 g in 1 TUBE	OINTMENT	28	5
0904-8805-31	Major Triple Antibiotic	1 in 1 BOX	OINTMENT	1	5
0904-8805-67	Major Triple Antibiotic	144 in 1 CARTON	OINTMENT	144	5
0904-8805-67	Major Triple Antibiotic	0.9 g in 1 PACKET	OINTMENT	0.9	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-8805-31	GM - Gram	0904-8805	1ddaba87-ed34-4e7e-a729-99f3a70b30d4	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-8805	MAJOR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFAT) OINTMENT [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20240918_a6cc3fbc-6302-4033-e053-2a95a90a19f0.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 · 434 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
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
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
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
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	a6cc3fbc-6302-4033-e053-2a95a90a19f0	5
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	a6cc3fbc-6302-4033-e053-2a95a90a19f0	5
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	a6cc3fbc-6302-4033-e053-2a95a90a19f0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-8805-31	00904880531	1 TUBE in 1 BOX (0904-8805-31) / 28 g in 1 TUBE	1 tube	2024-08-20		No	No	Current
0904-8805-67	00904880567	144 PACKET in 1 CARTON (0904-8805-67) / .9 g in 1 PACKET	144 packet	2020-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Triple Antibiotic Ointment	Major Pharmaceuticals \| Trifecta Pharmaceuticals USA LLC	2024-09-11	HUMAN OTC DRUG LABEL	5