Home NDC 0363-0552 Studio 35 External Analgesic Medicated Body
Product NDC 0363-0552
11-digit product format 003630552
Labeler code 0363
Product ID 0363-0552_4807fb60-8d08-6e61-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Zinc Oxide
Dosage form POWDER
Route TOPICAL
Labeler Walgreen Co
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-02-07
Substance MENTHOL; ZINC OXIDE
Active strength 1.5; 10 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Studio 35 External Analgesic Medicated Body
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1.5 mg/g ZINC OXIDE 10 mg/g
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 SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577232 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 0363-0552-38 Studio 35 External Analgesic Medicated Body 283 g in 1 BOTTLE POWDER 283 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0552 STUDIO 35 EXTERNAL ANALGESIC MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [WALGREEN CO] 1 Current NDC, Legacy NDC, 1 package rows 20170208_2dd63063-45c1-4029-99ac-0962a27a5ddc.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 1 of 1 · 1 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 0363-0552-38 00363055238 283 g in 1 BOTTLE (0363-0552-38) 283 g 2017-02-07 0000-00-00 No No Current