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 7 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
unii: 88AYB867L5
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
unii: 88AYB867L5
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
unii: 88AYB867L5
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
unii: 88AYB867L5
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsExact identifier
unii: 88AYB867L5
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Hydrocortisone AcetateHYDROCORTISONE ACETATEAvPAKd13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd2026-01-08Adverse reactionsExact identifier
unii: 3X7931PO74
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: X045WJ989B
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: 88AYB867L5
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
unii: 3X7931PO74
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: 88AYB867L5
Hemmorex-HCHYDROCORTISONE ACETATELaser Pharmaceuticals, LLCd625764a-6171-4802-9bc0-95e5785b8b7d2026-01-01Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 88AYB867L5
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
unii: 3X7931PO74
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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