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 4 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lynx LX0864 peachy-foam antiseptic handsoap	CHLOROXYLENOL	ABC Compounding Co., Inc.	dd8025cb-d160-83a4-e053-2a95a90a51ac	2026-05-11	Warnings	Exact identifier application number: M004
Satin Foam High Foaming Antiseptic Hand Wash	CHLOROXYLENOL	Certus Medical, Inc.	ea49da65-ae5e-bfde-e053-2a95a90adef2	2026-05-11	Warnings	Exact identifier application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876	CHLOROXYLENOL	Consolidated Chemicals, LLC	f17299a4-28d6-e65b-e053-2a95a90a05e7	2026-05-11	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCL	HARRIS TEETER LLC	4b0c0a3c-7145-97ca-e063-6394a90a1a96	2026-05-07	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC	HARRIS TEETER LLC	4e81590c-32d3-f8aa-e063-6294a90ab341	2026-05-06	Warnings	Exact identifier application number: M004
FIRSTAR TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	5b9434ad-83d7-4df3-bfef-3db152e6c6cc	2026-05-04	Warnings	Exact identifier application number: M004
oopsie First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	4 Visions LLC	50b21f0a-1e87-51ae-e063-6294a90a8a3c	2026-04-30	Warnings	Exact identifier application number: M004
First Aid Kit, Lil Drug Store	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Lil' Drug Store Products, Inc.	503c6c0e-3e1a-71ed-e063-6394a90abfa2	2026-04-24	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	23a35ba8-ebc6-4252-bb88-ec237425056c	2026-04-15	Warnings	Exact identifier application number: M004
El Valle Gentian Violet	GENTIAN VIOLET 1%	Pharmadel LLC	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	2026-04-13	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Sun Pharmaceutical Industries, Inc.	4afdeedf-9cdf-47d6-919f-ea907fda0290	2026-04-10	Warnings	Exact identifier application number: M004
Family Care Triple Antibiotic Original Formula 0.33oz	TRIPLE ANTIBIOTIC ORIGINAL FORMULA	United Exchange Corp	4f1ef127-a67e-ca60-e063-6394a90a3a3d	2026-04-10	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	H E B	2a143950-13b4-457e-91a4-c61a88aad84b	2026-04-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4e54f479-ad87-e86b-e063-6394a90aa6d2	2026-03-31	Warnings	Exact identifier application number: M004
El Valle Merthiolate	BENZALKONIUM CHLORIDE	Pharmadel LLC	fd7b28ca-9f71-0ff6-e053-6394a90a4822	2026-03-26	Warnings	Exact identifier application number: M004
sojo Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4d8429bd-24b9-ad3c-e063-6294a90aeba0	2026-03-21	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief Clubtray	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f4545718-8643-a340-e053-2995a90a0079	2026-03-18	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Preferred Pharmaceuticals Inc.	2f115e22-10f5-47fe-85df-f59e4387a373	2026-03-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cd49c65-e347-7589-e063-6394a90a53bd	2026-03-12	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cc6d822-f383-2ceb-e063-6294a90aecc7	2026-03-11	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