FDA.reportPublic FDA data

Hydrocortisone

Product NDC
49035-011
11-digit product format
490350011
Labeler code
49035
Product ID
49035-011_c6f191f3-8c5e-74ca-e053-2995a90af0a7
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-15
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/113g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-011DDiscontinued by firm2026-10-05
excluded packagepackage49035-01149035-011-40DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
OATINACTIVE INGREDIENTZ6J799EAJKHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-011HYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES INC]9Legacy NDC20241218_352199d1-d006-48b1-a940-1ba4b0011e54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-011-4049035001140113 g in 1 CAN (49035-011-40) 113 g2015-04-150000-00-00NoNoCurrent