Home NDC 69571-009-01 Family Wellness
Product NDC 69571-009
Requested package NDC 69571-009-01
11-digit product format 695710009
Labeler code 69571
Product ID 69571-009_08ad6eaa-df8b-8f2e-e063-6394a90a16b0
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE 1%
Dosage form CREAM
Route TOPICAL
Labeler FRONT PHARMACEUTICAL PLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-06-18
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 Family Wellness
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 69571-009-01 Family Wellness 28 g in 1 TUBE CREAM 28 2 69571-009-01 Family Wellness 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69571-009 FAMILY WELLNESS (HYDROCORTISONE 1%) CREAM [FRONT PHARMACEUTICAL PLC] 2 Current NDC, Legacy NDC, 2 package rows 20231027_ea26265d-f24e-458e-8bf0-287b2d49f4f4.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 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 Marketing end Sample Exclude flag Status 69571-009-01 69571000901 1 TUBE in 1 CARTON (69571-009-01) / 28 g in 1 TUBE 1 tube 2017-06-18 0000-00-00 No No Current