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 24 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
unii: 88AYB867L5
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
unii: 88AYB867L5
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
unii: 3X7931PO74
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
unii: 3X7931PO74
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
unii: 88AYB867L5
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
unii: 3X7931PO74
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
unii: 3X7931PO74
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone AcetateHYDROCORTISONE ACETATEBryant Ranch Prepack172e225e-9a00-4a5c-b209-8f3fa6b58d0f2024-01-11Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEBryant Ranch Prepack653fa10e-ab54-4b14-9ffa-8fd95b5e10402024-01-11Adverse reactionsExact identifier
unii: 3X7931PO74
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsExact identifier
unii: 88AYB867L5
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsExact identifier
unii: 88AYB867L5
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
unii: 88AYB867L5
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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