TRIPLE ANTIBIOTIC

Product NDC: 21922-101
11-digit product format: 219220101
Labeler code: 21922
Product ID: 21922-101_e439b001-c222-4bcd-b4cf-0bbfd652da5e
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Encube Ethicals, Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-06
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/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: TRIPLE ANTIBIOTIC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	500 [USP'U]/g
NEOMYCIN SULFATE	3.5 mg/g
POLYMYXIN B SULFATE	10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359350	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
dfea6b2e-cd76-439d-a3da-64e2d8717163	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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21922-101-04	TRIPLE ANTIBIOTIC	14 g in 1 TUBE	OINTMENT	14	2
21922-101-04	TRIPLE ANTIBIOTIC	1 in 1 CARTON	OINTMENT	1	2
21922-101-05	TRIPLE ANTIBIOTIC	1 in 1 CARTON	OINTMENT	1	2
21922-101-05	TRIPLE ANTIBIOTIC	28 g in 1 TUBE	OINTMENT	28	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-101-05	GM - Gram	21922-101	b2dc1641-bd1f-4026-96de-1145a47f4709	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21922-101	TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCL) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]	1	Current NDC, 4 package rows	20250419_dfea6b2e-cd76-439d-a3da-64e2d8717163.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Antibiotic plus Burn Relief	BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI	Trifecta Pharmaceuticals USA LLC	048871e2-c917-292d-e063-6394a90af130	2024-12-18	Warnings	Exact identifier application number: M004
TheraCare Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	0c3fc798-9a97-5316-e063-6394a90a6830	2024-12-18	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Rugby Laboratories	ac3c9897-c812-1360-e053-2a95a90ad591	2024-12-17	Warnings	Exact identifier application number: M004
Major Bacitracin	BACITRACIN ZINC	Major Pharmaceuticals	a23ce772-7078-0a4b-e053-2995a90aff0d	2024-12-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	eea0d90c-914b-2624-e053-2a95a90a34c9	2024-12-13	Warnings	Exact identifier application number: M004
OP First Aid Series TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	cadebf07-dd48-4855-8296-7a91e28d7123	2024-12-05	Warnings	Exact identifier application number: M004
triple antibiotic and pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	f0864d78-23e6-4e6c-bc67-7ba3e6dd862c	2024-12-03	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Publix Super Markets Inc	330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f9	2024-11-25	Warnings	Exact identifier application number: M004
WinCo Maximum Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE	WinCo Foods, LLC	01b03c7e-6c4e-43aa-8480-aff1c2688f7f	2024-11-21	Warnings	Exact identifier application number: M004
WinCo Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	WinCo Foods, LLC	e364b623-6e20-4894-8d4c-5c739be78f86	2024-11-21	Warnings	Exact identifier application number: M004
Winco Bacitracin Zinc	BACITRACIN ZINC	WinCo Foods, LLC	dcdf647f-fa32-4b72-b714-a77e8e332358	2024-11-21	Warnings	Exact identifier application number: M004
Walgreens Multi-Antibiotic with Pain Relief Cream	POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Walgreens Company	f4feccc3-ac25-4d8a-9b68-9a24f755524a	2024-11-20	Warnings	Exact identifier application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief Cream	POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Walgreens Company	fbc364d7-d8b8-43f5-99cc-290438f3982b	2024-11-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f9a48f73-aa12-cf68-e053-6294a90a8e53	2024-11-19	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Acme United Corporation	e55cbf7e-c955-7f1a-e053-2a95a90a3f28	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f4eba34c-ce31-3004-e053-2995a90a245b	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Neomycin Antibiotic	NEOMYCIN SULFATE	Acme United Corporation	c651e98e-aabe-de46-e053-2a95a90a6307	2024-11-19	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	f07d3bca-4312-46ed-b0c4-f886c01bd095	2024-11-14	Warnings	Exact identifier application number: M004
Polysporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	e0fcf83e-a374-4fc0-a629-873033054392	2024-11-14	Warnings	Exact identifier application number: M004
Neosporin Pain Itch Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	55392c48-b5d8-44cd-8c10-6d8668349848	2024-11-13	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
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical Ointment	PSN	dfea6b2e-cd76-439d-a3da-64e2d8717163	2
1359350	bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment	SCD	dfea6b2e-cd76-439d-a3da-64e2d8717163	2
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	SY	dfea6b2e-cd76-439d-a3da-64e2d8717163	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21922-101-04	21922010104	1 TUBE in 1 CARTON (21922-101-04) / 14 g in 1 TUBE	1 tube	2025-03-06	No	No	Current
21922-101-05	21922010105	1 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE	1 tube	2025-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triple antibiotic ointment + pain relief	Encube Ethicals, Inc. \| Encube Ethicals Private Limited	2025-09-25	HUMAN OTC DRUG LABEL	2