Home NDC 69968-0637 Aveeno Restorative Skin Therapy Itch Relief Balm
Product NDC 69968-0637
11-digit product format 699680637
Labeler code 69968
Product ID 69968-0637_21faa84e-83c4-e381-e063-6294a90ae7e4
Type HUMAN OTC DRUG
Nonproprietary name PRAMOXINE HYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler Kenvue Brands LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-01
Substance PRAMOXINE HYDROCHLORIDE
Active strength 5 mg/g
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 Aveeno Restorative Skin Therapy Itch Relief Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 5 mg/g
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 1150482 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 69968-0637-4 Aveeno Restorative Skin Therapy Itch Relief Balm 113 g in 1 TUBE CREAM 113 5 69968-0637-4 Aveeno Restorative Skin Therapy Itch Relief Balm 1 in 1 CARTON CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0637 AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM (PRAMOXINE HYDROCHLORIDE) CREAM [KENVUE BRANDS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241107_61824ca7-a2d3-4830-b2bb-149a3222bfc8.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 69968-0637-4 69968063704 1 TUBE in 1 CARTON (69968-0637-4) / 113 g in 1 TUBE 1 tube 2020-08-01 0000-00-00 No No Current