Home NDC 63868-959 QC Medicated anti itch
Product NDC 63868-959
11-digit product format 638680959
Labeler code 63868
Product ID 63868-959_28cd0b68-0d27-bc7b-e063-6294a90a53a1
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine hydrochloride, menthol
Dosage form CREAM
Route TOPICAL
Labeler Chain Drug Marketing Association
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-07
Substance MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength 1; 1 g/100g; g/100g
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 QC Medicated anti itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1 g/100g PRAMOXINE HYDROCHLORIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 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 1116155 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 63868-959-01 QC Medicated anti itch 1 in 1 CARTON CREAM 1 2 63868-959-01 QC Medicated anti itch 28 g in 1 TUBE CREAM 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-959 QC MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION] 2 Current NDC, Legacy NDC, 2 package rows 20241210_b5e41e3a-81df-3a63-e053-2a95a90a5839.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 73 of 152 · 3,029 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 63868-959-01 63868095901 1 TUBE in 1 CARTON (63868-959-01) / 28 g in 1 TUBE 1 tube 2020-12-07 0000-00-00 No No Current