Home NDC 63736-306 Caldesene Medicated Protecting
Product NDC 63736-306
11-digit product format 637360306
Labeler code 63736
Product ID 63736-306_954623a3-77db-4ff4-8b50-cbe143a16955
Type HUMAN OTC DRUG
Nonproprietary name Cornstarch and Zinc Oxide
Dosage form POWDER
Route TOPICAL
Labeler Insight Pharmaceuticals LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-15
Substance STARCH, CORN; ZINC OXIDE
Active strength 115; 21 g/142g; g/142g
NDC exclude flag No
Listing certified through 2027-12-31
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 Caldesene Medicated Protecting
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STARCH, CORN 115 g/142g ZINC OXIDE 21 g/142g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O8232NY3SJ Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039054 Internal RxNorm lookup 1039057 Internal RxNorm 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 63736-306-01 Caldesene Medicated Protecting 142 g in 1 BOTTLE POWDER 142 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63736-306 CALDESENE MEDICATED PROTECTING (CORNSTARCH AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240125_ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b.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 30 of 68 · 1,357 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 63736-306-01 63736030601 142 g in 1 BOTTLE (63736-306-01) 142 g 2017-07-15 0000-00-00 No No Current