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 20 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Safetec of America, Inc.	ca1df4a0-844d-4b1d-b972-f2704a8ebbab	2024-02-16	Warnings	Exact identifier application number: M004
Single Antibiotic	BACITRACIN ZINC	Safetec of America, Inc.	9993c204-6e61-4da3-90ef-2b7dfa09c920	2024-02-14	Warnings	Exact identifier application number: M004
Single Antibiotic with Neomycin	NEOMYCIN SULFATE	Safetec of America	e989cf7e-f3d1-42d2-af45-fc80095b97cb	2024-02-08	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	96c41fc1-81f9-4757-abc6-867b5383ed5d	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	2c2aa8af-2adb-4f59-ac20-15818d0e28e7	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	03c05028-5a5f-4690-a836-cc1b1044ab39	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	59494d5c-dd8a-431c-8e6a-4e1151ba7460	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC	BluePoint Laboratories	c47e15bd-1062-4cca-e053-2995a90a9075	2024-01-31	Warnings	Exact identifier application number: M004
Neomycin	NEOMYCIN OINTMENT	Dynarex Corporation	0f9e087b-6e86-a3c7-e063-6394a90ac8d4	2024-01-23	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Target Corporation	050be94c-1fbb-4d84-82c6-841aac8f318e	2024-01-18	Warnings	Exact identifier application number: M004
Leader Triple Antibiotic	FIRST AID TRIPLE ANTIBIOTIC	Cardinal Health 110,Inc.	844cd9a1-b68e-47d8-a5eb-c9e880ba019e	2024-01-18	Warnings	Exact identifier application number: M004
Multi-Action Antibiotic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT	Target Corporation	8fecff32-bd67-4351-90f7-0c28cb335ea3	2024-01-18	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	FIRST AID ANTIBIOTIC	Cardinal Health 110, Inc.	442e11aa-7d14-44f9-bf14-446018f1de0d	2024-01-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	7b16cb9b-5847-4360-9974-2118f4a2c70f	2024-01-17	Warnings	Exact identifier application number: M004
Green Guard Triple Antibiotic	BACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd456e2f-e6d7-d2ad-e053-2995a90a5c12	2024-01-17	Warnings	Exact identifier application number: M004
Medi-First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd432abc-fefb-1b4b-e053-2995a90acb18	2024-01-17	Warnings	Exact identifier application number: M004
Crane Safety Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Crane Safety LLC	96dbc282-4b3f-aaf3-e053-2995a90a5694	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Target Corporation	10c4a1b5-bb91-48da-b0ae-303e4adf793a	2024-01-17	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	Target Corporation	6020956d-2f58-4be8-97da-3f6b7e0f34aa	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	TRIPLE ANTIBIOTIC	Target Corporation	8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb	2024-01-17	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