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 31 of 53 · 1,045 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEBausch & Lomb Incorporatedb0ee85dd-5fe1-46a3-9bff-606e489d20b12025-04-30Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
YVTYVT DARK SPOT CORRECTORSQUALANE, NIACINAMIDEBeijing JUNGE Technology Co., Ltd.33d1d717-9af6-eaa0-e063-6394a90a87c52025-04-28WarningsExact identifier
unii: GW89575KF9
Nestabs ONEVITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHAWomens Choice Pharmaceuticals, LLC9b71b219-91ae-46b2-8fb5-d3d118d738732025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R0ZB2556P8
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACID OTICSaptalis Pharmaceuticals, LLCd9a3597c-2c9d-46cc-818b-8bb3aa5c4f322025-04-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
SILICONE SCAR CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd338180f7-2449-3d13-e063-6294a90a90832025-04-24WarningsExact identifier
unii: R0ZB2556P8
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
unii: GW89575KF9
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact identifier
unii: WI4X0X7BPJ
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
unii: WI4X0X7BPJ
Medicated Foaming FeminineLACTIC ACID, BORIC ACID, CHLORHEXIDINE GLUCONATE, CNIDIUM MONNIERI FRUIT, LEVOMENOLRida LLC02b3d683-05b0-4075-bbf9-e6d97c61765c2025-03-06WarningsExact identifier
unii: 24WE03BX2T
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
HydrocortisoneHYDROCORTISONEWalgreens Co.c22bba5c-bb6f-494e-987a-f6e36c1b48932025-03-06WarningsExact identifier
unii: WI4X0X7BPJ
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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