Home NDC 71927-031 American Safety and First Aid
Product NDC 71927-031
11-digit product format 719270031
Labeler code 71927
Product ID 71927-031_479b997e-a604-56a8-e063-6294a90adc70
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE ACETATE
Dosage form CREAM
Route TOPICAL
Labeler Orazen Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-11
Substance HYDROCORTISONE ACETATE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base American Safety and First Aid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71927-031-01 American Safety and First Aid 0.9 g in 1 POUCH CREAM 0.9 2 71927-031-02 American Safety and First Aid 25 in 1 BOX CREAM 25 2 71927-031-03 American Safety and First Aid 144 in 1 BOX CREAM 144 2
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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71927-031-01 71927003101 0.9 g in 1 POUCH 0.9 g Historical 71927-031-02 71927003102 25 POUCH in 1 BOX (71927-031-02) / .9 g in 1 POUCH (71927-031-01) 25 pouch 2025-12-11 No No Current 71927-031-03 71927003103 144 POUCH in 1 BOX (71927-031-03) / .9 g in 1 POUCH (71927-031-01) 144 pouch 2025-12-11 No No Current