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 6 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Water-Jel Neomycin Antibiotic	FIRST AID OINTMENT	Water-Jel Technologies	abea91a2-4453-406d-a7ed-3ffc19ef521a	2025-12-31	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic and Pain	PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	FSA Store Inc. (Caring Mills)	3c5b6909-6b30-5256-e063-6294a90a9096	2025-12-29	Warnings	Exact identifier application number: M004
Caring Mills Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	fbd11419-4513-10d7-e053-6394a90ac82b	2025-12-27	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Veridian Healthcare	8cd0cd64-fe62-4225-8986-5e8641dd6df2	2025-12-22	Warnings	Exact identifier application number: M004
PS-2261 Triple Antibiotic, 0.5g	PS-2261 TRIPLE ANTIBIOTIC, 0.5G	ProStat First Aid LLC	0072f8de-fc06-d529-e063-6294a90a08db	2025-12-15	Warnings	Exact identifier application number: M004
PS - 2895 Triple Antibiotic , 0.5g	PS - 2895 TRIPLE ANTIBIOTIC , 0.5G	Prostat First Aid LLC	0050de33-914b-f76d-e063-6394a90a7fab	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	ProStat First Aid	f76d7d18-0fa1-d943-e053-6294a90ac20a	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	Front Line Safety	0f509f96-a083-37d1-e063-6394a90a622c	2025-12-15	Warnings	Exact identifier application number: M004
ElixirTripleGuard Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	ELIXIR HEALTHCARE USA, LLC.	43edfb80-4d50-9362-e063-6394a90a2199	2025-12-13	Warnings	Exact identifier application number: M004
El Valle Decolorized Iodine	ALCOHOL	Pharmadel LLC	fd7a227b-536c-b3f7-e053-6394a90a4158	2025-12-04	Warnings	Exact identifier application number: M004
Vitastem First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	3970ac49-ab0f-4492-ba61-95a12faed500	2025-12-02	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Fourstar Group USA, Inc	2f916502-4daf-4cb9-a638-f37bb96c8077	2025-12-02	Warnings	Exact identifier application number: M004
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	ea16e1de-0100-456b-abe6-d33de78221da	2025-12-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC OINTMENT	Lil' Drug Store Products, Inc.	44e5107e-832a-2ce6-e063-6294a90a711d	2025-12-01	Warnings	Exact identifier application number: M004
Viaderma Care First Aid Antibiotic	BACITRACIN ZINC	VIADERMA DISTRIBUTION INC	0f36f396-e479-486c-b047-2760477609e2	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	New World Imports, Inc	1982b664-e8fd-4030-aa89-f7543e1b487b	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	New World Imports, Inc	9c2d417e-6fec-42f4-9f0c-2ec79de9342d	2025-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	5b0249c0-c196-4d3c-973f-49bd2d3d4a75	2025-12-01	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Henry Schein	eaf03943-c7a5-724e-e053-2995a90a3e6c	2025-11-25	Warnings	Exact identifier application number: M004
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Henry Schein	ead9496b-112e-59e6-e053-2995a90a768c	2025-11-25	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