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 21 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOEHYDROCORTISONEClick Industries LLC328c389c-7e05-4892-a9b3-b6a753f4935a2025-08-25WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
unii: T5L8T28FGP
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Incff34da77-5e96-4ed1-8c28-ba0b2f35576a2025-08-20Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
unii: WI4X0X7BPJ
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
unii: T5L8T28FGP
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
unii: T5L8T28FGP
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsd2c40b07-dc39-46c6-8ea1-b288589a46d12025-08-18Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
unii: T5L8T28FGP
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
unii: T5L8T28FGP
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
SurviveX Hydrocortisone CreamHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.3bd1da8d-5142-798c-e063-6294a90a7be62025-08-07WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
Cortizone 10 CoolingHYDROCORTISONEChattem, Inc.14d9fce2-9f54-4204-83cb-161de8a303f02025-08-01WarningsExact identifier
unii: WI4X0X7BPJ
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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