Home NDC 11383-313 Anti-itch Paraben Free
Product NDC 11383-313
11-digit product format 113830313
Labeler code 11383
Product ID 11383-313_0c5419c5-0928-7ca6-e063-6294a90ac0a7
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler Weeks & Leo Co., Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-03
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 Anti-itch Paraben Free
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 · 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 11383-313-01 Anti-itch Paraben Free 28 g in 1 TUBE CREAM 28 1 11383-313-01 Anti-itch Paraben Free 1 in 1 CARTON CREAM 1 1 11383-313-02 Anti-itch Paraben Free 1 in 1 CARTON CREAM 1 1 11383-313-02 Anti-itch Paraben Free 56 g in 1 TUBE CREAM 56 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11383-313 ANTI-ITCH PARABEN FREE (HYDROCORTISONE) CREAM [WEEKS & LEO CO., INC.] 1 Current NDC, 4 package rows 20231213_0c5419c5-0929-7ca6-e063-6294a90ac0a7.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 Sample Exclude flag Status 11383-313-01 11383031301 1 TUBE in 1 CARTON (11383-313-01) / 28 g in 1 TUBE 1 tube 2023-03-03 No No Current 11383-313-02 11383031302 1 TUBE in 1 CARTON (11383-313-02) / 56 g in 1 TUBE 1 tube 2023-03-03 No No Current