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 10 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
unii: 88AYB867L5
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
unii: 88AYB867L5
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: 88AYB867L5
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 88AYB867L5
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone AcetateHYDROCORTISONE ACETATEMarlex Pharmaceuticals, Inc.e60473f7-fd00-a477-e053-2a95a90ad4dd2025-11-13Adverse reactionsExact identifier
unii: 3X7931PO74
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.fecf8380-3bb5-11e5-98c5-0002a5d5c51b2025-11-08Adverse reactionsExact identifier
rxcui: 1294025
unii: 88AYB867L5
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.1469733e-1723-4b8c-be33-ed8dfafd65e22025-11-08Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.f207bdff-2f41-4eee-818e-198b6462863e2025-11-08Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 88AYB867L5
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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