PENIMIXCINA

Product NDC: 69729-615
11-digit product format: 697290615
Labeler code: 69729
Product ID: 69729-615_18ae5c8b-2507-fac3-e063-6394a90a6072
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: OPMX LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-05
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 500; 5; 5000; 10 [iU]/g; mg/g; [iU]/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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69729-615-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-615-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-615-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-615-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-615-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69729-615-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69729-615-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69729-615-05	`9bebd1f3094a…`	`5416666fcb17…`

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: PENIMIXCINA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	500 [iU]/g
NEOMYCIN SULFATE	5 mg/g
POLYMYXIN B SULFATE	5000 [iU]/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
2055751	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
92bcbc02-9683-4117-af2b-6d4687796f1f	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-05-19	Penimixcina - First Aid Ointment
2024-01-30	Penimixcina - First Aid Ointment
2022-10-19	Penimixcina - First Aid Ointment
2020-01-31	Penimixcina - First Aid Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-615-01	PENIMIXCINA	14 g in 1 TUBE	OINTMENT	14		5
69729-615-05	PENIMIXCINA	1 in 1 BOX	OINTMENT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-615	PENIMIXCINA (BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [OPMX LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240521_92bcbc02-9683-4117-af2b-6d4687796f1f.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 12 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lights Povidone Iodine Scrub	POVIDONE-IODINE	Lights Medical Manufacture Co., Ltd.	5e1eef53-c2c7-477e-9ee4-19c01c1881e5	2025-05-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN ZINC	Trifecta Pharmaceuticals USA, LLC.	4a9fe0fa-5549-4e06-e054-00144ff8d46c	2025-05-15	Warnings	Exact identifier application number: M004
SionBiotext Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Sion Biotext Medical Ltd	35083d42-5823-eeb1-e063-6294a90acafa	2025-05-13	Warnings	Exact identifier application number: M004
Multi Action	BACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	b98082f3-be95-49fb-e053-2a95a90a37b8	2025-05-13	Warnings	Exact identifier application number: M004
Leader Triple antibiotic and pain relief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Cardinal Health 110 dba LEADER	f4c521d9-dd05-1c23-e053-2995a90a6e2c	2025-05-13	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Trifecta Pharmaceuticals USA	34f1db74-6506-d53d-e063-6394a90ac400	2025-05-12	Warnings	Exact identifier application number: M004
Triple Antibiotic plus Lidocaine	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINE	TRIFECTA PHARMACEUTICALS USA LLC	14fda967-54ba-c964-e063-6294a90a21ee	2025-04-24	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Front Pharmaceutical PLC	3244d91e-6c6b-a351-e063-6294a90aa02d	2025-04-08	Warnings	Exact identifier application number: M004
Walgreens Advanced Wound Hydrogel	ALLANTOIN, BENZETHONIUM CHLORIDE	WALGREEN COMPANY	25c6ada8-4a16-0896-e063-6294a90a0fdb	2025-04-08	Warnings	Exact identifier application number: M004
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	13c1f2df-ba52-45e0-8868-a7518e9cdb55	2025-04-07	Warnings	Exact identifier application number: M004
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	93a6e02e-9f4b-4821-afa2-2029769f3088	2025-04-07	Warnings	Exact identifier application number: M004
burn gel 01	MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3227bdc9-9323-68eb-e063-6294a90a29d2	2025-04-06	Warnings	Exact identifier application number: M004
Vitastem ULTRA	BACITRACIN ZINC	ViaDerma Distribution, Inc	fd96cc09-8522-44a5-b034-0d30e532410d	2025-04-03	Warnings	Exact identifier application number: M004
Vitastem Ultra First Aid Antibiotic	BACITRACIN ZINC	Viaderma Distribution Inc	e6986bf9-22ea-4484-a709-27bc91c9058d	2025-03-18	Warnings	Exact identifier application number: M004
Redicare Triple Antibiotic First Aid	TRIPLE ANTIBIOTIC FIRST AID OINTMENT	Redicare LLC	9468979d-446e-e4be-e053-2995a90a3f21	2025-03-05	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	0ad21575-0e2d-24c2-e063-6394a90a616e	2025-02-21	Warnings	Exact identifier application number: M004
The Life Safety Pro Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	64a7331f-98a6-4052-85b9-695c83b3bd16	2025-02-19	Warnings	Exact identifier application number: M004
Vitastem	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	a6630858-7038-425f-8a75-bb25f36a0dbe	2025-02-18	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	Sheffield Pharmaceuticals LLC	1aa95046-c1f7-4fc7-acac-839065d998f6	2025-02-17	Warnings	Exact identifier application number: M004
Equate	BACITRACIN ZINC ANTIBIOTIC OINTMENT	Walmart Inc.	20908780-8803-4e19-e063-6394a90aab87	2025-02-01	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
2055751	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	PSN	92bcbc02-9683-4117-af2b-6d4687796f1f	5
2055751	bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment	SCD	92bcbc02-9683-4117-af2b-6d4687796f1f	5
2055751	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	SY	92bcbc02-9683-4117-af2b-6d4687796f1f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-615-01	69729061501	14 g in 1 TUBE	14 g					Historical
69729-615-05	69729061505	1 TUBE in 1 BOX (69729-615-05) / 14 g in 1 TUBE (69729-615-01)	1 tube	2018-09-05	0000-00-00	No	No	Current