Home NDC 41167-0033 Cortizone 10 Cooling
Product NDC 41167-0033
11-digit product format 411670033
Labeler code 41167
Product ID 41167-0033_cb74d908-48c8-4ef2-982b-a4b05a69ae0c
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form GEL
Route TOPICAL
Labeler Chattem, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Cortizone 10 Cooling
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198706 Internal RxNorm lookup 846161 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 41167-0033-2 Cortizone 10 Cooling 28 g in 1 TUBE GEL 28 4 41167-0033-2 Cortizone 10 Cooling 1 in 1 CARTON GEL 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41167-0033 CORTIZONE 10 COOLING (HYDROCORTISONE) GEL [CHATTEM, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231026_14d9fce2-9f54-4204-83cb-161de8a303f0.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 41167-0033-2 41167003302 1 TUBE in 1 CARTON (41167-0033-2) / 28 g in 1 TUBE 1 tube 2023-01-01 0000-00-00 No No Current