Home NDC 82895-716 Westlake Anti-itch
Product NDC 82895-716
11-digit product format 828950716
Labeler code 82895
Product ID 82895-716_0c53d505-4d34-bb34-e063-6394a90abc7b
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler Westlake Pharma LLC
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 Westlake Anti-itch
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 82895-716-30 Westlake Anti-itch 28 g in 1 TUBE CREAM 28 1 82895-716-30 Westlake Anti-itch 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82895-716 WESTLAKE ANTI-ITCH (HYDROCORTISONE) CREAM [WESTLAKE PHARMA LLC] 1 Current NDC, 2 package rows 20231213_0c53c982-3f23-a2d5-e063-6394a90acd55.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 82895-716-30 82895071630 1 TUBE in 1 CARTON (82895-716-30) / 28 g in 1 TUBE 1 tube 2023-03-03 No No Current