Home NDC 80641-013 Drops
Product NDC 80641-013
11-digit product format 806410013
Labeler code 80641
Product ID 80641-013_2e99f7af-047a-769c-e063-6394a90a1406
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone Octisalate Octocrylene
Dosage form LIQUID
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-07
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 2.9; 4.9; 7.6 g/100mL; g/100mL; g/100mL
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 Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.9 g/100mL OCTISALATE 4.9 g/100mL OCTOCRYLENE 7.6 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM 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 80641-013-01 Drops 1 in 1 KIT LIQUID 1 4 80641-013-80 Drops 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4 80641-013-94 Drops 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-013 DROPS (AVOBENZONE OCTISALATE OCTOCRYLENE) LIQUID [VACATION INC.] 4 Current NDC, 3 package rows 20250223_1319d6ea-a580-79c5-e063-6394a90a4dca.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 80641-013-01 80641001301 1 BOTTLE, DROPPER in 1 KIT (80641-013-01) / 30 mL in 1 BOTTLE, DROPPER (80641-013-94) 2024-03-07 No No Current 80641-013-80 80641001380 30 mL in 1 BOTTLE, DROPPER (80641-013-80) 30 ml 2024-03-07 No No Current 80641-013-94 80641001394 30 mL in 1 BOTTLE, DROPPER 30 ml Historical