Hydrocortisone

Product NDC
53943-984
Requested package NDC
53943-984-01
11-digit product format
539430984
Labeler code
53943
Product ID
53943-984_a2bb39ee-b305-b640-e053-2995a90a597e
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Discount Drug Mart, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-10-30
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-984-012023-02-17C16284748780-1f386c64a-41df-0266-e053-dadaa90a7c1aDiscount Drug Mart Hydrocortisone 1% cream
53943-984-012023-01-30C16284748780-1f386c64a-41df-0266-e053-dadaa90a7c1aDiscount Drug Mart Hydrocortisone 1% cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9HYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [DISCOUNT DRUG MART, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-984-01539430984011 TUBE in 1 BOX (53943-984-01) > 28 g in 1 TUBE1 tube2015-10-300000-00-00NoNoCurrent