Ora Zen Triple Antibiotic

Product NDC: 71927-034
11-digit product format: 719270034
Labeler code: 71927
Product ID: 71927-034_4cc7d45b-44bd-c250-e063-6294a90a54d0
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Orazen Inc
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-11
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400; .0035; 5000 [USP'U]/g; g/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

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: Ora Zen Triple Antibiotic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [USP'U]/g
NEOMYCIN SULFATE	.0035 g/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
abbf8c34-87cb-4366-9840-7264a5114b54	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	Strength	SPL version
71927-034-01	Ora Zen Triple Antibiotic	0.5 g in 1 POUCH	OINTMENT	0.5		1
71927-034-02	Ora Zen Triple Antibiotic	25 in 1 BOX	OINTMENT	25		1

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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Kroger Company	e31c8d92-bf9f-4b7f-8f81-54199745cd20	2024-10-06	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	American Sales Company	9df0c4c2-f045-4f25-878e-4d55a99b8df4	2024-10-06	Warnings	Exact identifier application number: M004
DG Health Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	0a04da51-d169-4eff-b70c-352913ce3966	2024-10-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	8d5bac6b-98b6-4fc4-983a-ca5292b4c361	2024-10-06	Warnings	Exact identifier application number: M004
antibiotic plus pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Kroger Company	91828614-d0d1-472f-802f-43f473860125	2024-09-26	Warnings	Exact identifier application number: M004
DG Health Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp Inc	efaf3ea5-0a2f-414f-96eb-7e8cfba9e901	2024-09-26	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	29c223ff-3cb7-4578-a326-08516e89cd47	2024-09-26	Warnings	Exact identifier application number: M004
Signature Care First Aid Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	78ecfb28-f4c4-4f70-90c9-d6d7bf920fb5	2024-09-26	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amerisource Bergen	3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40	2024-09-26	Warnings	Exact identifier application number: M004
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Exact identifier application number: M004
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Exact identifier application number: M004
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Padagis Israel Pharmaceuticals Ltd	28fff253-ddd4-4669-aa90-b4caf48c905f	2024-09-22	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Safeway	044aff98-f398-40f5-8c18-2751b4ab4384	2024-09-18	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	American Sales Company	09a0b0b9-1806-4ff9-80fa-448dabbf2cc7	2024-09-18	Warnings	Exact identifier application number: M004
equaline first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	United Natural Foods, Inc. dba UNFI	022e009e-0192-4089-86f3-4d63448e0f88	2024-09-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Kroger Company	c531bac4-ab15-4fde-99a7-19e20ce10387	2024-09-17	Warnings	Exact identifier application number: M004
basic care first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Amazon.com Services LLC	c159b18d-0d6e-409f-8b2b-e8f28cd85633	2024-09-17	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	503c6c0e-3e1a-71ed-e063-6394a90abfa2	1
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	abbf8c34-87cb-4366-9840-7264a5114b54	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	503c6c0e-3e1a-71ed-e063-6394a90abfa2	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	abbf8c34-87cb-4366-9840-7264a5114b54	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	503c6c0e-3e1a-71ed-e063-6394a90abfa2	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	abbf8c34-87cb-4366-9840-7264a5114b54	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71927-034-01	71927003401	0.5 g in 1 POUCH	0.5 g				Historical
71927-034-02	71927003402	25 POUCH in 1 BOX (71927-034-02) / .5 g in 1 POUCH (71927-034-01)	25 pouch	2026-03-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Kit, Orazen Inc	Orazen Inc	2026-06-03	HUMAN OTC DRUG LABEL	3
First Aid Kit, Lil' Drug Store ®	Lil' Drug Store Products, Inc.	2026-04-24	HUMAN OTC DRUG LABEL	1
71927-034, ORA-ZEN Triple Antibiotic Ointment	Orazen Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-03-11	HUMAN OTC DRUG LABEL	1