Home NDC 82635-403 Melan RX
Product NDC 82635-403
11-digit product format 826350403
Labeler code 82635
Product ID 82635-403_42f3c4f9-335e-595e-e063-6294a90a20f0
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Melan RX
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-23
Substance ZINC OXIDE
Active strength 132 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 Melan RX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 132 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82635-403-01 Melan RX 45 mL in 1 BOTTLE LOTION 45 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82635-403 MELAN RX (ZINC OXIDE) LOTION [MELAN RX] 3 Current NDC, 1 package rows 20241027_f4bdf20c-b6bc-55f1-e053-2995a90ac308.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82635-403-01 82635040301 45 mL in 1 BOTTLE (82635-403-01) 45 ml 2022-03-23 No No Current