FDA.reportPublic FDA data

NDC 66915-531 - Refuge HC

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
66915-531
Package NDCs from labels
66915-531-01, 66915-531-02
Manufacturer
CoValence Inc.
Effective date
2011-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsCoValence Inc.2011-08-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66915-531-01Refuge HC30 g in 1 JARCREAM302
66915-531-02Refuge HC200000 g in 1 DRUMCREAM2000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66915-531REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]22 package rows20110819_5bcdd479-b645-4209-9413-643dfa405c0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JOREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
HEDYCHIUM CORONARIUM ROOTINACTIVE INGREDIENT92A6N0IQN9REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784UREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4YREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8IREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
SQUALANEINACTIVE INGREDIENTGW89575KF9REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8REFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9QREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREFUGE HC (HYDROCORTISONE) CREAM [COVALENCE INC.]2

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 47 of 53 · 1,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
unii: PDC6A3C0OX
Bloop Itch Soothing TopicalHYDROCORTISONEThree Nations Corp0b64677e-d4bf-0929-e063-6294a90af1372023-11-30WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEA-S Medication Solutions5ee2f62a-d8d5-4efd-bf6f-f79c108556312023-11-22Adverse reactionsExact identifier
unii: WI4X0X7BPJ
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsab640d62-f470-4b50-818f-0c0a339047432023-11-21Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
unii: WI4X0X7BPJ
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
unii: WI4X0X7BPJ
Ana Cool Rapid Soothing Cooling FormulaHYDROCORTISONEAna-Cool, LLC64b80cc2-e2d8-4535-aaf8-c031f4159cd12023-11-05WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.0f17c50f-3761-4470-bf3b-63837a287b8a2023-10-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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