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 41 of 61 · 1,206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
unii: 89Y4M234ES
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Rite Aid Cala Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Rite Aide29a9d59-4c7c-81aa-e053-2995a90a70562024-12-15WarningsExact identifier
unii: 88AYB867L5
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
unii: 89Y4M234ES
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsExact identifier
unii: 88AYB867L5
Pramoxine Itch reliefPRAMOXINE HCL 1%CVSe947694c-c122-0291-e053-2995a90ac39a2024-12-11WarningsExact identifier
unii: 88AYB867L5
Blistex Ivarest Poison Ivy ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEBlistex Inc.e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a2024-12-11WarningsExact identifier
unii: 88AYB867L5
QC Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLChain Drug Marketing Associationb5e41e3a-81df-3a63-e053-2a95a90a58392024-12-08WarningsExact identifier
unii: 88AYB867L5
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: 88AYB867L5
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
unii: 4T6H12BN9U
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
unii: 4T6H12BN9U
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
unii: 4T6H12BN9U
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
unii: 4T6H12BN9U
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
unii: 88AYB867L5
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
unii: 89Y4M234ES
unii: 057Y626693
unii: 88AYB867L5
unii: 19371312D4
ZINC OXIDEZINC OXIDEVIVE HEALTH LLC284dbf6a-6fa2-742b-e063-6394a90afdfd2024-12-02WarningsExact identifier
unii: 4T6H12BN9U
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
unii: 4T6H12BN9U
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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