Home NDC 51326-128 Hybrid SPF
Product NDC 51326-128
11-digit product format 513260128
Labeler code 51326
Product ID 51326-128_6e898b78-e4b8-4cad-a2a0-b3b05ebcffab
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene, Octisalate, Zinc Oxide
Dosage form SPRAY
Route TOPICAL
Labeler Topiderm, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-07
Substance OCTOCRYLENE; OCTISALATE; ZINC OXIDE
Active strength 80; 50; 50 mg/mL; mg/mL; mg/mL
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 Hybrid SPF
Brand name suffix SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 80 mg/mL OCTISALATE 50 mg/mL ZINC OXIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup 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 51326-128-01 Hybrid SPFSPF 30 177 mL in 1 CAN SPRAY 177 2
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 51326-128-01 51326012801 177 mL in 1 CAN (51326-128-01) 177 ml 2024-10-07 No No Current