FDA.reportPublic FDA data

NDC 47682-397-99 - 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
47682-397
Requested NDC
47682-397-99
Package NDCs from labels
47682-397-71, 47682-397-12, 47682-397-99, 47682-397-73, 47682-397-35
Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone - Unifirst First Aid CorporationUnifirst First Aid Corporation2025-09-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-397-12Hydrocortisone10 in 1 BOXCREAM1014
47682-397-12Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-35Hydrocortisone144 in 1 BAGCREAM14414
47682-397-35Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-71Hydrocortisone0.9 g in 1 PACKETCREAM0.914
47682-397-71Hydrocortisone20 in 1 BOXCREAM2014
47682-397-73Hydrocortisone25 in 1 BOXCREAM2514
47682-397-99Hydrocortisone0.9 g in 1 PACKETCREAM0.914

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-397HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]13Current NDC, Legacy NDC, 8 package rows20240118_69d6645e-db3c-4dc0-a9a5-e2bc963e2f28.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
alcoholINACTIVE INGREDIENT3K9958V90MHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
paraffinINACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
white waxINACTIVE INGREDIENT7G1J5DA97FHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3

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 52 of 335 · 6,695 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
rxcui: 106258
unii: WI4X0X7BPJ
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsExact identifier
application number: M017
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care LILY WATER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.898829cb-23e0-431b-be67-246c245b3dd52026-05-12WarningsExact identifier
unii: 3K9958V90M
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.02ab1006-c7c8-42c9-bda8-62c9d71425212026-05-11Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERETHYL ALCOHOLLESSDOTW CO.,LTD.518657d5-9ee6-f8ca-e063-6294a90af5952026-05-11WarningsExact identifier
unii: 3K9958V90M
Beverly Gel Hand SanitizerETHYL ALCOHOLCleanslate Group LLC0e999251-cb51-ceec-e063-6294a90a35ad2026-05-11WarningsExact identifier
unii: 3K9958V90M
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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