Home NDC 84857-545 Dr Edward Krulig New Melan Sunblock SPF 50
Product NDC 84857-545
11-digit product format 848570545
Labeler code 84857
Product ID 84857-545_25c22608-ce97-dd0c-e063-6394a90a3a97
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTISALATE, OCTOCRYLENE
Dosage form LIQUID
Route TOPICAL
Labeler KRULIG INTERNATIONAL, INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-14
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 30; 50; 100 mg/mL; mg/mL; mg/mL
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 Dr Edward Krulig New Melan Sunblock SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 100 mg/mL
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 84857-545-00 Dr Edward Krulig New Melan Sunblock SPF 50 100 mL in 1 BOTTLE LIQUID 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84857-545 DR EDWARD KRULIG NEW MELAN SUNBLOCK SPF 50 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LIQUID [KRULIG INTERNATIONAL, INC] 1 Current NDC, 1 package rows 20241101_21c301d2-b283-40e1-bf26-b4bdde278247.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 84857-545-00 84857054500 100 mL in 1 BOTTLE (84857-545-00) 100 ml 2024-10-14 No No Current