Triple Antibiotic

Product NDC: 51672-2120
11-digit product format: 516722120
Labeler code: 51672
Product ID: 51672-2120_534599e8-fece-b9dc-e063-6294a90ad09a
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-12-15
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400; 3.5; 5000 [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: Triple Antibiotic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [iU]/g
NEOMYCIN SULFATE	3.5 mg/g
POLYMYXIN B SULFATE	5000 [iU]/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
d77239e6-5e81-439a-b0cd-f8be59169442	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
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
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
51672-2120-1	Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	5
51672-2120-1	Triple Antibiotic	14.2 g in 1 TUBE	OINTMENT	14.2	5
51672-2120-2	Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	5
51672-2120-2	Triple Antibiotic	28.4 g in 1 TUBE	OINTMENT	28.4	5
51672-2120-3	Triple Antibiotic	60 g in 1 TUBE	OINTMENT	60	5
51672-2120-3	Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	5
51672-2120-6	Triple Antibiotic	0.9 g in 1 APPLICATOR	OINTMENT	0.9	5
51672-2120-6	Triple Antibiotic	6 in 1 CARTON	OINTMENT	6	5
51672-2120-8	Triple Antibiotic	0.9 g in 1 APPLICATOR	OINTMENT	0.9	5
51672-2120-8	Triple Antibiotic	15 in 1 CARTON	OINTMENT	15	5
51672-2120-9	Triple Antibiotic	144 in 1 CARTON	OINTMENT	144	5
51672-2120-9	Triple Antibiotic	0.9 g in 1 APPLICATOR	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
51672-2120-1	GM - Gram	51672-2120	161fa1c5-9889-4d4d-b06e-da422f00f3a3	1	2016-05-16
51672-2120-2	GM - Gram	51672-2120	44e5c044-5369-45b0-b1d4-5711f5d65f74	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2120	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]	4	Current NDC, Legacy NDC, 12 package rows	20240427_d77239e6-5e81-439a-b0cd-f8be59169442.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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	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	d77239e6-5e81-439a-b0cd-f8be59169442	5
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	d77239e6-5e81-439a-b0cd-f8be59169442	5
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	d77239e6-5e81-439a-b0cd-f8be59169442	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2120-1	51672212001	1 TUBE in 1 CARTON (51672-2120-1) / 14.2 g in 1 TUBE	1 tube	2015-12-15	0000-00-00	No	No	Current
51672-2120-2	51672212002	1 TUBE in 1 CARTON (51672-2120-2) / 28.4 g in 1 TUBE	1 tube	2015-12-15	0000-00-00	No	No	Current
51672-2120-3	51672212003	1 TUBE in 1 CARTON (51672-2120-3) / 60 g in 1 TUBE	1 tube	2015-12-15	0000-00-00	No	No	Current
51672-2120-6	51672212006	6 APPLICATOR in 1 CARTON (51672-2120-6) / .9 g in 1 APPLICATOR	6 applicator	2021-09-20	0000-00-00	No	No	Current
51672-2120-8	51672212008	15 APPLICATOR in 1 CARTON (51672-2120-8) / .9 g in 1 APPLICATOR	15 applicator	2021-09-20	0000-00-00	No	No	Current
51672-2120-9	51672212009	144 APPLICATOR in 1 CARTON (51672-2120-9) / .9 g in 1 APPLICATOR	144 applicator	2021-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triple Antibiotic	NuCare Pharmaceutical, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	1
Triple Antibiotic	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc. \| GOPALDAS VISRAM AND COMPANY LIMITED	2026-06-02	HUMAN OTC DRUG LABEL	7