Home NDC 51316-141 Pramoxine Itch relief
Product NDC 51316-141
11-digit product format 513160141
Labeler code 51316
Product ID 51316-141_28f13725-48d9-8774-e063-6394a90a6704
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine HCl 1%
Dosage form CREAM
Route TOPICAL
Labeler CVS
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-25
Substance PRAMOXINE HYDROCHLORIDE
Active strength 1 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 Pramoxine Itch relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 g/100g
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 1052684 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 51316-141-12 Pramoxine Itch relief 340 g in 1 JAR CREAM 340 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-141 PRAMOXINE ITCH RELIEF (PRAMOXINE HCL 1%) CREAM [CVS] 3 Current NDC, 1 package rows 20241213_e947694c-c122-0291-e053-2995a90ac39a.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 78 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 51316-141-12 51316014112 340 g in 1 JAR (51316-141-12) 340 g 2023-04-25 No No Current