Home NDC 0496-0586 DerMend Moisturizing Anti-Itch
Product NDC 0496-0586
11-digit product format 004960586
Labeler code 0496
Product ID 0496-0586_297a5495-6a56-857c-e063-6394a90a531e
Type HUMAN OTC DRUG
Nonproprietary name pramoxine hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Ferndale Laboratories, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-03-01
Substance PRAMOXINE HYDROCHLORIDE
Active strength 10 mg/mL
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 DerMend Moisturizing Anti-Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246075 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 0496-0586-08 DerMend Moisturizing Anti-Itch 237 mL in 1 BOTTLE LOTION 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0496-0586 DERMEND MOISTURIZING ANTI-ITCH (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241219_14c7fb1c-a310-4b12-ab2e-7f1c0801995c.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 0496-0586-08 00496058608 237 mL in 1 BOTTLE (0496-0586-08) 237 ml 2017-03-01 0000-00-00 No No Current