Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate

Product NDC: 0404-0171
11-digit product format: 004040171
Labeler code: 0404
Product ID: 0404-0171_5d41b051-4fd6-6334-e063-6394a90a76e4
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Henry Schein
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-11-04
Substance: POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
Active strength: 50000; 5; 400 [iU]/g; mg/g; [iU]/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

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: Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYMYXIN B SULFATE	50000 [iU]/g
NEOMYCIN SULFATE	5 mg/g
BACITRACIN ZINC	400 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19371312D4	Internal UNII lookup
057Y626693	Internal UNII lookup
89Y4M234ES	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
eadb847e-aefe-41cf-e053-2995a90af2cd	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
0404-0171-50	2024-01-31	C162847	48780-1	1030e365-0ab0-111a-e063-dadaa90a10e2	570-3130 Triple Antibiotic NDC 0404-0171-50
0404-0171-50	2024-01-31	C162847	48780-1	1030e365-0ab0-111a-e063-dadaa90a10e2	570-3130 Triple Antibiotic NDC 0404-0171-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-0171-50	Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	72 in 1 CASE	OINTMENT	72		4
0404-0171-50	Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	1 in 1 BOX	OINTMENT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-0171	BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE OINTMENT [HENRY SCHEIN]	3	Current NDC, Legacy NDC, 2 package rows	20241129_eadb847e-aefe-41cf-e053-2995a90af2cd.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
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC

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	eadb847e-aefe-41cf-e053-2995a90af2cd	4
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	eadb847e-aefe-41cf-e053-2995a90af2cd	4
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	eadb847e-aefe-41cf-e053-2995a90af2cd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-0171-50	00404017150	72 BOX in 1 CASE (0404-0171-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE	72 box	2022-11-04	0000-00-00	No	No	Current