Tripleantibioticointmentandpainrelief

Product NDC: 69396-044
11-digit product format: 693960044
Labeler code: 69396
Product ID: 69396-044_29b3e33a-544c-40b4-e063-6394a90a1107
Type: HUMAN OTC DRUG
Nonproprietary name: Family Wellness Bacitracin,Neomycin,PolymyxinB,Pramoxine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Trifecta Pharmaceutical USA LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-30
Substance: BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength: 500; 3.5; 10; 10000 [USP'U]/100g; mg/100g; mg/100g; [USP'U]/100g
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: Tripleantibioticointmentandpainrelief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN	500 [USP'U]/100g
NEOMYCIN SULFATE	3.5 mg/100g
PRAMOXINE HYDROCHLORIDE	10 mg/100g
POLYMYXIN B SULFATE	10000 [USP'U]/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58H6RWO52I	Internal UNII lookup
057Y626693	Internal UNII lookup
88AYB867L5	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
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
91575333-5268-5d8f-e053-2a95a90a7a89	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	Strength	SPL version
69396-044-01	Tripleantibioticointmentandpainrelief	28.4 g in 1 TUBE	OINTMENT	28.4		4
69396-044-01	Tripleantibioticointmentandpainrelief	1 in 1 BOX	OINTMENT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-044	TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF (FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE) OINTMENT [TRIFECTA PHARMACEUTICAL USA LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241222_91575333-5268-5d8f-e053-2a95a90a7a89.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 15 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Kids Multi-Antibiotic with Pain Relief Cream	POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Walgreens Company	fbc364d7-d8b8-43f5-99cc-290438f3982b	2024-11-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f9a48f73-aa12-cf68-e053-6294a90a8e53	2024-11-19	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Acme United Corporation	e55cbf7e-c955-7f1a-e053-2a95a90a3f28	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Acme United Corporation	f4eba34c-ce31-3004-e053-2995a90a245b	2024-11-19	Warnings	Exact identifier application number: M004
First Aid Only Neomycin Antibiotic	NEOMYCIN SULFATE	Acme United Corporation	c651e98e-aabe-de46-e053-2a95a90a6307	2024-11-19	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	f07d3bca-4312-46ed-b0c4-f886c01bd095	2024-11-14	Warnings	Exact identifier application number: M004
Polysporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	e0fcf83e-a374-4fc0-a629-873033054392	2024-11-14	Warnings	Exact identifier application number: M004
Neosporin Pain Itch Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	55392c48-b5d8-44cd-8c10-6d8668349848	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Kids Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	6752f0a0-2432-4d8b-8198-74ae96a68963	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	a3e6fe2e-1b74-4f22-9c7c-a00057439690	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	32302dcd-f3f1-408b-ae5f-e7d8b666f68f	2024-11-13	Warnings	Exact identifier application number: M004
NEOSPORIN Plus BURN RELIEF	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	3caa7fd1-bd66-427e-a6c0-1b137b205089	2024-11-13	Warnings	Exact identifier application number: M004
Simply Neosporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	68bfecea-095f-4d3f-b077-d86e1b9f1faa	2024-11-13	Warnings	Exact identifier application number: M004
Triple Antibiotic and Burn Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	fdc510b8-f3ad-4bd6-a8d0-1b81e9f30e13	2024-11-13	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	ALLIED TRADE LINK LLC	253e5b98-c64f-3226-e063-6294a90a9352	2024-11-12	Warnings	Exact identifier application number: M004
TRIPLET ANTIBIOTIC	TRIPLET ANTIBIOTIC	ALLIED TRADE LINK LLC	26bd5ba4-264b-2a28-e063-6394a90ada80	2024-11-12	Warnings	Exact identifier application number: M004
basic care first aid antibiotic and burn relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Amazon.com Services LLC	0df4c44d-6912-4db9-a703-a82da4c8ae76	2024-11-11	Warnings	Exact identifier application number: M004
SUPER SENSITIVE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	7d4a5b21-82d2-4904-9577-4a9b2579076e	2024-11-08	Warnings	Exact identifier application number: M004
dg health triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	4c97dada-966f-4de8-b5d9-e939cb456aea	2024-11-06	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	de07139e-ece9-424b-8468-f5ed4bbb2b2b	2024-11-06	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
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
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical Ointment	PSN	91575333-5268-5d8f-e053-2a95a90a7a89	4
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	91575333-5268-5d8f-e053-2a95a90a7a89	4
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	SY	91575333-5268-5d8f-e053-2a95a90a7a89	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-044-01	69396004401	1 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE	1 tube	2019-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triple Antibiotic Ointment + Pain Relief	Trifecta Pharmaceutical USA LLC	2024-12-20	HUMAN OTC DRUG LABEL	4