Home NDC 53943-986-01 Hydrocortisone
Product NDC 53943-986
Requested package NDC 53943-986-01
11-digit product format 539430986
Labeler code 53943
Product ID 53943-986_b7b82bd8-c623-fe80-e053-2a95a90a03b1
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler Discount Drug Mart, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-01-30
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 10 mg/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53943-986 53943-986-01 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA INACTIVE INGREDIENT 1211AIM8G7 HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 SODIUM CETYL SULFATE INACTIVE INGREDIENT 3V3Y3O7BIQ HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE OINTMENT [DISCOUNT DRUG MART, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53943-986-01 53943098601 1 TUBE in 1 BOX (53943-986-01) > 28 g in 1 TUBE 1 tube 2015-10-30 0000-00-00 No No Current