Home NDC 80476-101 PLUMSCREEN
Product NDC 80476-101
11-digit product format 804760101
Labeler code 80476
Product ID 80476-101_47d5defe-1b5d-7e14-e063-6294a90a4de8
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Le Prunier Farms, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-21
Substance ZINC OXIDE
Active strength 4.7 g/100mL
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 PLUMSCREEN
Brand name suffix SPF 31
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 4.7 g/100mL
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 80476-101-02 PLUMSCREENSPF 31 2 mL in 1 PACKET CREAM 2 4 80476-101-10 PLUMSCREENSPF 31 10 mL in 1 TUBE CREAM 10 4 80476-101-10 PLUMSCREENSPF 31 1 in 1 BOX CREAM 1 4 80476-101-60 PLUMSCREENSPF 31 1 in 1 BOX CREAM 1 4 80476-101-60 PLUMSCREENSPF 31 60 mL in 1 TUBE CREAM 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80476-101 PLUMSCREEN SPF 31 (ZINC OXIDE) CREAM [LE PRUNIER FARMS, INC.] 3 Current NDC, Legacy NDC, 5 package rows 20240530_e20eb996-2b64-6bd0-e053-2a95a90a4f92.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 128 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80476-101-02 80476010102 2 mL in 1 PACKET (80476-101-02) 2 ml 2024-01-04 No No Current 80476-101-10 80476010110 1 TUBE in 1 BOX (80476-101-10) / 10 mL in 1 TUBE 1 tube 2022-06-21 0000-00-00 No No Current 80476-101-60 80476010160 1 TUBE in 1 BOX (80476-101-60) / 60 mL in 1 TUBE 1 tube 2022-06-21 0000-00-00 No No Current