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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACITRACIN	BACITRACIN	Meijer Distribution Inc	029e7150-1b9a-47c9-90bd-5f8bcd21365c	2024-10-29	Warnings	Exact identifier application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	A-S Medication Solutions	01131ba6-6d5b-4710-bec3-ba1769c08c79	2024-10-22	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	CVS Pharmacy	15ea4415-943a-4d0a-ac23-5f37cd2cf206	2024-10-22	Warnings	Exact identifier application number: M004
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	3ba24e32-7078-45fb-85d1-2ab252fa9cb5	2024-10-16	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	43486da5-6e8b-45c0-bd7e-cc2d8b28c510	2024-10-16	Warnings	Exact identifier application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin Zinc	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production (Xiamen) Co., Ltd.	af08c1fe-fb1a-56d2-e053-2a95a90a67c4	2024-10-15	Warnings	Exact identifier application number: M004
Exchange Select First Aid Triple Anitbiotic Pain Relieving	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Army & Air Force Exchange Service	1c7f1700-69c0-4a71-8bb0-a71e3082efeb	2024-10-14	Warnings	Exact identifier application number: M004
antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	55fa94cb-7e1c-41bc-879a-5618a828f14a	2024-10-14	Warnings	Exact identifier application number: M004
first aid antibiotic and pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer, Inc.	f0892a30-8a88-44e8-ab04-0e87c12f9c44	2024-10-14	Warnings	Exact identifier application number: M004
triple antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	d97a69e8-4058-4c77-b628-ad3e2b97a620	2024-10-14	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	b541f1a9-7e40-4c35-840f-ea1e357b580e	2024-10-14	Warnings	Exact identifier application number: M004
Exchange Select triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Army & Air Force Exchange Service	b7bf899c-44e5-48d6-bf8e-d843fd442432	2024-10-12	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Topco Associates LLC	675665ee-bd0d-4168-81b8-341b1258c102	2024-10-12	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Changjian Medical Products Co., Ltd.	34e8776c-1f36-4e1b-9d71-727591ac904d	2024-10-11	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	H E B	58a4d263-e234-43cd-a3bd-b19a492174d9	2024-10-11	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	5e0fc39b-e6d4-4543-8afc-2881e2f85f9b	2024-10-06	Warnings	Exact identifier application number: M004
Good Sense Triple Antibiotic and Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	c3e9215f-fcef-4938-8208-df4099652289	2024-10-06	Warnings	Exact identifier application number: M004
triple antibiotic plus maximum strength	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	c428b0a3-e80a-493c-ac67-807ebca3ce01	2024-10-06	Warnings	Exact identifier application number: M004
Basic Care First Aid Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amazon.com Services LLC	a9247f69-0366-42dd-ae0d-39a2a6976cdc	2024-10-06	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