Tripleantibioticapainscaritch

Product NDC: 69396-045
11-digit product format: 693960045
Labeler code: 69396
Product ID: 69396-045_29b3ad9e-827e-f9c8-e063-6294a90a598e
Type: HUMAN OTC DRUG
Nonproprietary name: Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL
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; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 500; 3.5; 10000; 10 [USP'U]/100g; mg/100g; [USP'U]/100g; mg/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

Additional Listing Data#

Field, Values table
Field	Values
Unii	58H6RWO52I, 057Y626693, 19371312D4, 88AYB867L5
Rxcui	1359350

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
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69396-045-01	Tripleantibioticapainscaritch	28.4 g in 1 TUBE	OINTMENT	28.4		4
69396-045-01	Tripleantibioticapainscaritch	1 in 1 BOX	OINTMENT	1		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-045	TRIPLEANTIBIOTICAPAINSCARITCH (FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL) OINTMENT [TRIFECTA PHARMACEUTICAL USA LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241222_935106c6-8a9e-07fa-e053-2a95a90a2484.zip

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
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

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	935106c6-8a9e-07fa-e053-2a95a90a2484	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	935106c6-8a9e-07fa-e053-2a95a90a2484	4
1359350	bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment	SY	935106c6-8a9e-07fa-e053-2a95a90a2484	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-045-01	69396004501	1 TUBE in 1 BOX (69396-045-01) / 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 Pain Scar Itch	Trifecta Pharmaceutical USA LLC	2024-12-20	HUMAN OTC DRUG LABEL	4