triple antibiotic

Product NDC: 0363-0539
11-digit product format: 003630539
Labeler code: 0363
Product ID: 0363-0539_9aca2de8-106b-49dc-9aa3-bba16b33be39
Type: HUMAN OTC DRUG
Nonproprietary name: bacitracin zinc, neomycin, polymyxin B
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Walgreen Company
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-07
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400; 3.5; 5000 [USP'U]/g; mg/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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0363-0539	0363-0539-16	D	Discontinued by firm	2026-10-21
excluded package	package	0363-0539	0363-0539-26	D	Discontinued by firm	2026-10-21
excluded package	package	0363-0539	0363-0539-58	D	Discontinued by firm	2026-10-21

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 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0363-0539-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0539-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0539-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0539-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0539-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0539-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0539-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0539-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0539-26	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0539-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0539-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0539-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0539-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0539-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0539-26	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0539-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0539-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0539-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0539-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0539-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0539-26	`367a005e9d99…`	`383a685ebd0f…`

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: triple antibiotic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [USP'U]/g
NEOMYCIN SULFATE	3.5 mg/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
4f3cfe39-2df8-48b4-954d-5997217c92ba	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
0363-0539-16	triple antibiotic	56 g in 1 TUBE	OINTMENT	56	12
0363-0539-16	triple antibiotic	1 in 1 CARTON	OINTMENT	1	12
0363-0539-26	triple antibiotic	56 g in 1 TUBE	OINTMENT	56	12
0363-0539-26	triple antibiotic	2 in 1 CARTON	OINTMENT	2	12
0363-0539-64	triple antibiotic	1 in 1 CARTON	OINTMENT	1	12
0363-0539-64	triple antibiotic	28 g in 1 TUBE	OINTMENT	28	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0539-58	GM - Gram	0363-0539	0d9403ce-b5c3-4cb4-b7fd-e04a2bc5c2ec	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
COTTONSEED OIL	INACTIVE INGREDIENT	H3E878020N	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2
SODIUM PYRUVATE	INACTIVE INGREDIENT	POD38AIF08	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0539	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]	12	Current NDC, Legacy NDC, 6 package rows	20250305_4f3cfe39-2df8-48b4-954d-5997217c92ba.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balma Septic Antiseptic Hand Wash	BENZALKONIUM CHLORIDE	Rochester Midland Corporation	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	2025-01-10	Warnings	Exact identifier application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380	CHLOROXYLENOL	ABC Compounding Co., Inc.	efa3938f-64de-77ba-e053-2a95a90ac840	2025-01-10	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	64aa660d-2d69-48e8-bd0d-4876815d89ff	2025-01-08	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Water-Jel Technologies	412928a1-3708-4fa8-99c5-aaa2b079cf6e	2025-01-06	Warnings	Exact identifier application number: M004
AVON HeXashield Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Tai Guk Pharm. Co., Ltd.	8e0cb861-d8aa-1f71-e053-2a95a90aaa88	2025-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	087694c2-4b1b-e293-e063-6294a90a961f	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	TRIFECTA PHARMACEUTICALS USA LLC	0c017b10-29b6-e30f-e063-6294a90a8a3c	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	0bf08cf6-be3f-f9aa-e063-6294a90a4393	2024-12-31	Warnings	Exact identifier application number: M004
Single Antibiotic with Bacitracin	BACITRACIN ZINC	Randob Labs Ltd.	2a807f1b-986f-a9ea-e063-6394a90aed25	2024-12-30	Warnings	Exact identifier application number: M004
Tripleantibioticapainscaritch	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	935106c6-8a9e-07fa-e053-2a95a90a2484	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	00c52a31-9bfa-a8bf-e063-6294a90ac4d7	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	Trifecta Pharmaceuticals Usa Llc	d04b397c-1608-4fd9-be28-ef7285d6a996	2024-12-20	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	91575333-5268-5d8f-e053-2a95a90a7a89	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Max Strength Antibiotic plus pain relief	PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Pharmacy Value Alliance LLC	9767821e-054b-3bd3-e053-2a95a90a4b0e	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab843664-a1e0-6716-e053-2995a90a2063	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Bacitracin Zinc	BACITRACIN ZINC	Pharmacy Value Alliance LLC	99d789be-aa85-0917-e053-2a95a90acd13	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab863d90-1a8f-3c1f-e053-2a95a90aa0a7	2024-12-20	Warnings	Exact identifier application number: M004
Family Wellness First Aid Antibiotic	FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA, LLC	9157681a-3ed1-096e-e053-2a95a90a05e3	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Original	FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B	Trifecta Pharmaceuticals USA LLC.	915759af-0d4f-6a87-e053-2a95a90acbd6	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Pain Scar Itch	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Trifecta Pharmaceutical USA LLC	9e507ec5-310d-3a21-e053-2a95a90a15a6	2024-12-18	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	4f3cfe39-2df8-48b4-954d-5997217c92ba	12
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	4f3cfe39-2df8-48b4-954d-5997217c92ba	12
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	4f3cfe39-2df8-48b4-954d-5997217c92ba	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0539-16	00363053916	1 TUBE in 1 CARTON (0363-0539-16) > 56 g in 1 TUBE	1 tube	2015-08-29	0000-00-00	No	No	Current
0363-0539-26	00363053926	2 TUBE in 1 CARTON (0363-0539-26) > 56 g in 1 TUBE	2 tube	2015-11-24	0000-00-00	No	No	Current
0363-0539-58	00363053958	1 TUBE in 1 CARTON (0363-0539-58) > 14 g in 1 TUBE	1 tube	2015-08-26	0000-00-00	No	No	Current
0363-0539-64	00363053964	1 TUBE in 1 CARTON (0363-0539-64) / 28 g in 1 TUBE	1 tube	2015-05-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreen Co. Triple Antibiotic Ointment Drug Facts	Walgreen Company	2026-08-31	HUMAN OTC DRUG LABEL	13