Home NDC 85455-100 burnd
Product NDC 85455-100
11-digit product format 854550100
Labeler code 85455
Product ID 85455-100_4df29d85-4168-2ee1-e063-6294a90ab080
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octinoxate, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler BURND LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-09
Substance HOMOSALATE; OCTINOXATE; ZINC OXIDE
Active strength 8; 7.5; 8.1 g/100mL; g/100mL; 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 burnd
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 8 g/100mL OCTINOXATE 7.5 g/100mL ZINC OXIDE 8.1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4Y5P7MUD51 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 85455-100-01 burnd 100 mL in 1 TUBE LOTION 100 7 85455-100-61 burnd 7.5 mL in 1 PACKET LOTION 7.5 7 85455-100-62 burnd 5.9 mL in 1 PACKET LOTION 5.9 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85455-100 BURND (HOMOSALATE, OCTINOXATE, ZINC OXIDE) LOTION [2 OARS INVESTMENTS DBA BURND] 1 Current NDC, 3 package rows 20250410_31cf923e-fdde-790b-e063-6294a90a60ee.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 85455-100-01 85455010001 100 mL in 1 TUBE (85455-100-01) 100 ml 2025-04-09 No No Current 85455-100-61 85455010061 7.5 mL in 1 PACKET (85455-100-61) 7.5 ml 2025-04-09 No No Current 85455-100-62 85455010062 5.9 mL in 1 PACKET (85455-100-62) 5.9 ml 2025-04-09 No No Current