Home NDC 69396-050 Hydrocortisone 1%
Product NDC 69396-050
11-digit product format 693960050
Labeler code 69396
Product ID 69396-050_4c363aee-bd3b-680f-e063-6294a90a283b
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals Usa Llc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-12
Substance HYDROCORTISONE
Active strength 1 g/100g
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 Hydrocortisone 1%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ 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 69396-050-01 Hydrocortisone 1% 1 in 1 BOX CREAM 1 7 69396-050-01 Hydrocortisone 1% 28.4 g in 1 TUBE CREAM 28.4 7 69396-050-05 Hydrocortisone 1% 14.2 g in 1 TUBE CREAM 14.2 7 69396-050-05 Hydrocortisone 1% 1 in 1 BOX CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-050 HYDROCORTISONE 1% (HYDROCORTISONE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250509_9987165c-1a0f-dd57-e053-2a95a90ae735.zip
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 8 of 156 · 3,115 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69396-050-01 69396005001 1 TUBE in 1 BOX (69396-050-01) / 28.4 g in 1 TUBE 1 tube 2019-12-12 0000-00-00 No No Current 69396-050-05 69396005005 1 TUBE in 1 BOX (69396-050-05) / 14.2 g in 1 TUBE 1 tube 2022-09-01 0000-00-00 No No Current