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 19 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin ZincBACITRACIN ZINCChain Drug Marketing Association Inc.1cd9ded3-068c-496e-e063-6394a90a6a0b2024-07-09WarningsExact identifier
application number: M004
Anti-Itch with AloeHYDROCORTISONE 1%Chain Drug Marketing Association Inc.1cbea7cd-03a0-1469-e063-6294a90a7cc12024-07-08WarningsExact identifier
application number: M004
astonea First AidBACITRACIN ZINCASTONEA LABS PRIVATE LIMITEDde0b2e06-64bc-78f0-e053-2995a90a39a02024-06-25WarningsExact identifier
application number: M004
Publix Bacitracin ZincBACITRACIN ZINCPUBLIX SUPER MARKETS, INC.51f21123-7826-40c9-b2aa-b202125085e22024-06-17WarningsExact identifier
application number: M004
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
application number: M004
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
application number: M004
QC Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Chain Drug Marketing Association1a1501a4-75b0-5900-e063-6394a90ad77a2024-06-04WarningsExact identifier
application number: M004
Always Save Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC1a00df31-a38a-fc82-e063-6394a90abbf32024-06-03WarningsExact identifier
application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINEOPMX LLC7c0d3cdf-af50-4a65-a01b-a33510feeb942024-05-17WarningsExact identifier
application number: M004
PENIMIXCINABACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDEOPMX LLC92bcbc02-9683-4117-af2b-6d4687796f1f2024-05-17WarningsExact identifier
application number: M004
Triple Antibiotic First Aid AntibioticBACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATEUniversal Distribution Center LLC78f00296-267b-44c3-a9e3-c40f122e905e2024-05-14WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEJHK Inc dba American Safety & First Aid26e66025-9457-42b3-9319-51302c17506e2024-04-26WarningsExact identifier
application number: M004
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004

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