Home NDC 83021-402 AnubisMed
Product NDC 83021-402
11-digit product format 830210402
Labeler code 83021
Product ID 83021-402_049fca13-6921-d895-e063-6294a90a42da
Type HUMAN OTC DRUG
Nonproprietary name Azelaic Acid, Salicylic Acid
Dosage form LIQUID
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M006
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-10-26
Marketing end 2027-09-08
Substance AZELAIC ACID; POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; ISOPROPYL ALCOHOL; WATER; SALICYLIC ACID; ALCOHOL
Active strength 7; 4.9965; 10; 2.7; 1.62; 1; 22.68 g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; mL/50mL
Pharmacologic classes Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC exclude flag No
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 AnubisMed Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID 7 g/50mL POLYETHYLENE GLYCOL 400 4.9965 g/50mL PROPYLENE GLYCOL 10 g/50mL ISOPROPYL ALCOHOL 2.7 g/50mL WATER 1.62 mL/50mL SALICYLIC ACID 1 g/50mL ALCOHOL 22.68 mL/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83021-402-50 AnubisMed 50 mL in 1 BOTTLE, GLASS LIQUID 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-402 ANUBISMED (AZELAIC ACID, SALICYLIC ACID) LIQUID [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230906_ebf3153d-30f5-54e4-e053-2995a90a74b1.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 30 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83021-402-50 83021040250 50 mL in 1 BOTTLE, GLASS (83021-402-50) 50 ml 2022-10-26 2027-09-08 No No Current