FDA.reportPublic FDA data

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
IngredientStrength
BACITRACIN500 [USP'U]/100g
NEOMYCIN SULFATE3.5 mg/100g
PRAMOXINE HYDROCHLORIDE10 mg/100g
POLYMYXIN B SULFATE10000 [USP'U]/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup
057Y626693Internal UNII lookup
88AYB867L5Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91575333-5268-5d8f-e053-2a95a90a7a89Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-044-01Tripleantibioticointmentandpainrelief28.4 g in 1 TUBEOINTMENT28.44
69396-044-01Tripleantibioticointmentandpainrelief1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-044TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF (FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE) OINTMENT [TRIFECTA PHARMACEUTICAL USA LLC]4Current NDC, Legacy NDC, 2 package rows20241222_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 13 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact identifier
application number: M004
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
ndc (product): 69396-044

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN91575333-5268-5d8f-e053-2a95a90a7a894
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD91575333-5268-5d8f-e053-2a95a90a7a894
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY91575333-5268-5d8f-e053-2a95a90a7a894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-044-01693960044011 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE1 tube2019-09-220000-00-00NoNoCurrent