Home NDC 41167-0344 Cortizone 10 Water Resistant
Product NDC 41167-0344
11-digit product format 411670344
Labeler code 41167
Product ID 41167-0344_7fa83555-178b-476a-a1a6-ee1e2246b681
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
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 Water Resistant
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 203105 Internal RxNorm lookup 206314 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 41167-0344-0 Cortizone 10 Water Resistant 28 g in 1 TUBE OINTMENT 28 4 41167-0344-0 Cortizone 10 Water Resistant 1 in 1 CARTON OINTMENT 1 4 41167-0344-5 Cortizone 10 Water Resistant 56 g in 1 TUBE OINTMENT 56 4 41167-0344-5 Cortizone 10 Water Resistant 1 in 1 CARTON OINTMENT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41167-0344 CORTIZONE 10 WATER RESISTANT (HYDROCORTISONE) OINTMENT [CHATTEM, INC.] 3 Current NDC, Legacy NDC, 4 package rows 20231207_118e55e7-241f-44c4-959e-09bf6221bd77.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 41167-0344-0 41167034400 1 TUBE in 1 CARTON (41167-0344-0) / 28 g in 1 TUBE 1 tube 2023-01-01 0000-00-00 No No Current 41167-0344-5 41167034405 1 TUBE in 1 CARTON (41167-0344-5) / 56 g in 1 TUBE 1 tube 2023-01-01 0000-00-00 No No Current