FDA.reportPublic FDA data

NDC 69729-616-01 - PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69729-616
Requested NDC
69729-616-01
Package NDCs from labels
69729-616-01, 69729-616-61
Manufacturer
OPMX LLC
Effective date
2024-05-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF - OPMX LLCOPMX LLC2024-05-17HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-17Pentrexcilina Triple Antibiotic
2024-01-30Pentrexcilina Triple Antibiotic
2022-10-19Pentrexcilina Triple Antibiotic
2020-01-31Pentrexcilina Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-616-01PENTREXCILINA TRIPLE ANTIBIOTICPLUS PAIN RELIEF14 g in 1 TUBEOINTMENT143
69729-616-61PENTREXCILINA TRIPLE ANTIBIOTICPLUS PAIN RELIEF1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-616PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE) OINTMENT [OPMX LLC]3Current NDC, Legacy NDC, 2 package rows20240518_7c0d3cdf-af50-4a65-a01b-a33510feeb94.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 37 of 61 · 1,206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
unii: 4T6H12BN9U
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
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: 4T6H12BN9U
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
unii: 89Y4M234ES
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 88AYB867L5
unii: 19371312D4
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: 4T6H12BN9U
unii: 88AYB867L5
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 4T6H12BN9U
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
unii: 89Y4M234ES
Neomycin and Polymyxin B Sulfates and Bacitracin ZincNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINCBausch & Lomb Incorporatedf3231f1c-665e-4efa-baa1-83bf296b2f8f2025-01-02Warnings, Adverse reactionsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONEBausch & Lomb Incorporated3b00eb5c-dd98-467e-a883-04c37a8ecc422025-01-02Warnings, Adverse reactionsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
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
unii: 89Y4M234ES
unii: 057Y626693
unii: 88AYB867L5
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 88AYB867L5
unii: 19371312D4
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
unii: 4T6H12BN9U
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.