FDA.reportPublic FDA data

NDC 45802-472-01 - Hydrocortisone Acetate Pramoxine Hcl

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
45802-472
Requested NDC
45802-472-01
Package NDCs from labels
45802-472-64, 45802-472-01, 45802-472-53, 45802-472-65
Manufacturer
Bryant Ranch Prepack
Effective date
2025-10-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2024-12-26HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2023-07-18HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2023-07-18HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Bryant Ranch PrepackBryant Ranch Prepack2023-07-18HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Acetate Pramoxine Hcl - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2022-05-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-472-01Hydrocortisone Acetate Pramoxine Hcl4 g in 1 TUBECREAM46
45802-472-53Hydrocortisone Acetate Pramoxine Hcl12 in 1 CARTONCREAM126
45802-472-64Hydrocortisone Acetate Pramoxine Hcl28.35 g in 1 TUBECREAM28.356
45802-472-64Hydrocortisone Acetate Pramoxine Hcl1 in 1 CARTONCREAM16
45802-472-65Hydrocortisone Acetate Pramoxine Hcl30 in 1 CARTONCREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-472HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 5 package rows20241218_87a4c494-56f9-48f6-8592-d610c507a4fc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-472-53GM - Gram45802-47256b71bf4-5df3-4cec-be2c-70a8db887f4c12012-07-24
45802-472-64GM - Gram45802-472c5d01896-7a24-435c-9d52-321746694d7712012-07-24
45802-472-65GM - Gram45802-4725d8db879-a930-4bfd-9688-b919705a62d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PRAMOXINEACTIVE MOIETY068X84E056HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
TROLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAAHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [PERRIGO NEW YORK INC]1

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 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
unii: 88AYB867L5
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
unii: 88AYB867L5
Neosporin Kids Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC6752f0a0-2432-4d8b-8198-74ae96a689632024-11-13WarningsExact identifier
unii: 88AYB867L5
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
unii: 88AYB867L5
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
unii: 88AYB867L5
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
unii: 88AYB867L5
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
unii: 88AYB867L5
LidocortLIDOCAINE HCL - HYDROCORTISONE ACETATEPureTek Corporationae49ddc6-26f0-7f92-e053-2995a90ab2f92024-11-11Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
basic care first aid antibiotic and burn reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC0df4c44d-6912-4db9-a703-a82da4c8ae762024-11-11WarningsExact identifier
unii: 88AYB867L5
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
unii: 6DC9Q167V3
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
unii: 88AYB867L5
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
unii: 88AYB867L5
dg health triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC4c97dada-966f-4de8-b5d9-e939cb456aea2024-11-06WarningsExact identifier
unii: 88AYB867L5
good sense triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companye9e913d8-8ec8-4465-ad3a-b524f6710a0f2024-11-06WarningsExact identifier
unii: 88AYB867L5
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLSafeway46db4b66-85a2-47fc-a643-df6477e2ddff2024-11-06WarningsExact identifier
unii: 88AYB867L5
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsExact identifier
unii: 88AYB867L5
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
unii: 88AYB867L5
Antibiotic, Pain and ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLCVS Pharmacy8bb6cb64-103f-454a-95ad-c2c56b9cf71a2024-11-05WarningsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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