Home NDC 55910-442 Avobenzone, Homosalate, Octisalate
Product NDC 55910-442
11-digit product format 559100442
Labeler code 55910
Product ID 55910-442_4c110e1b-5525-3dea-e063-6294a90a97f6
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form SPRAY
Route TOPICAL
Labeler Old East Main Co.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-25
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 30; 120; 50 mg/g; mg/g; mg/g
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 Avobenzone, Homosalate, Octisalate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 120 mg/g OCTISALATE 50 mg/g
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 V06SV4M95S Internal UNII lookup 4X49Y0596W 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 55910-442-14 Avobenzone, Homosalate, Octisalate 156 g in 1 BOTTLE, SPRAY SPRAY 156 5 55910-442-39 Avobenzone, Homosalate, Octisalate 312 g in 1 BOTTLE, SPRAY SPRAY 312 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-442 AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [OLD EAST MAIN CO.] 3 Current NDC, 2 package rows 20240727_b3d2da09-d9c9-4c27-82fe-a434ece2f099.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 55910-442-14 55910044214 156 g in 1 BOTTLE, SPRAY (55910-442-14) 156 g 2023-08-11 No No Current 55910-442-39 55910044239 312 g in 1 BOTTLE, SPRAY (55910-442-39) 312 g 2023-08-11 No No Current