Home NDC 41167-0338 Cortizone 10 Itch Relief Massaging Rollerball
Product NDC 41167-0338
11-digit product format 411670338
Labeler code 41167
Product ID 41167-0338_b9549cca-8fa2-45fd-9d02-b01202ac24ed
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Chattem, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-02
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 Cortizone 10 Itch Relief Massaging Rollerball
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup 206352 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 41167-0338-0 Cortizone 10 Itch Relief Massaging Rollerball 1 in 1 CARTON CREAM 1 5 41167-0338-0 Cortizone 10 Itch Relief Massaging Rollerball 42 g in 1 BOTTLE, WITH APPLICATOR CREAM 42 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41167-0338 CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL (HYDROCORTISONE) CREAM [CHATTEM, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241127_1e27682c-f856-41f1-9935-37540960a4c7.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 Marketing start Marketing end Sample Exclude flag Status 41167-0338-0 41167033800 1 BOTTLE, WITH APPLICATOR in 1 CARTON (41167-0338-0) / 42 g in 1 BOTTLE, WITH APPLICATOR 2023-01-02 0000-00-00 No No Current