FDA.reportPublic FDA data

NDC 51672-3003-00 - Hydrocortisone

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
51672-3003
Requested NDC
51672-3003-00
Package NDCs from labels
51672-3003-0, 51672-3003-2, 51672-3003-00
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Cream USP, 1% Cream USP, 2.5%Preferred Pharmaceuticals Inc.2026-05-11HUMAN PRESCRIPTION DRUG LABEL
HYDROCORTISONE - DIRECT RXDIRECT RX2026-03-05HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Cream USP, 1% Cream USP, 2.5%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-10-02HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Cream USP, 1% Cream USP, 2.5%NuCare Pharmaceuticals,Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2014-01-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-3003-0Hydrocortisone1 in 1 CARTONCREAM18
51672-3003-0Hydrocortisone20 g in 1 TUBECREAM208
51672-3003-2Hydrocortisone1 in 1 CARTONCREAM18
51672-3003-2Hydrocortisone28.35 g in 1 TUBECREAM28.358

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-3003HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20231219_e4f22e9c-cf38-473a-8f7d-8da7fd696f76.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-3003-2GM - Gram51672-300356359cbc-d0e5-4fd6-b2c4-b483640c103312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [DIRECT RX]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [DIRECT RX]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [DIRECT RX]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [DIRECT RX]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [DIRECT RX]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [DIRECT RX]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [DIRECT RX]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [DIRECT RX]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 4 of 45 · 896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Barmicil PlusHYDROCORTISONEOPMX LLC5698207f-9223-f3a6-e063-6294a90a8ab62026-07-14WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Quadriderm NFHYDROCORTISONEOPMX LLC5643f850-e0d4-d8d8-e063-6294a90a42602026-07-10WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
rxcui: 106258
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: T5L8T28FGP
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
unii: T5L8T28FGP
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.560a4abf-31dd-333f-e063-6294a90a35052026-07-08WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONE LOTIONAllegis Holdings LLC1a27d8fa-4025-ed68-e063-6394a90a4f372026-07-08Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Ala-ScalpHYDROCORTISONEDerm Ventures LLC61498a40-3b3c-4066-89c8-d99686e2d6382026-07-08Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
rxcui: 106258
Cysndra Ringworm CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangzhou Xinhongda Trading Service Co., Ltd.55ed83eb-0e67-e516-e063-6394a90af4432026-07-06WarningsExact identifier
unii: WI4X0X7BPJ
DIPROSPANHYDROCORTISONEOPMX LLC55fa9ecb-b843-5748-e063-6294a90a2d532026-07-06WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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