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 55 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Acne Gly-Sal 2-2 Foaming Cleanser SALICYLIC ACID Topiderm, Inc. 811dbf95-2b39-45c5-99a2-33c3c9d19570 2019-12-19 Warnings Exact identifier application number: M006 REPLENIX ACNE SOLUTIONS WASH BENZOYL PEROXIDE Topiderm, Inc. 8dc2d27d-3cc4-4874-b4c2-32607849b205 2019-12-17 Warnings Exact identifier application number: M006 REPLENIX ACNE Solution BENZOYL PEROXIDE WASH BENZOYL PEROXIDE Topiderm, Inc. 235e9dd5-13f2-4078-9807-1d87fd9e6cba 2019-12-17 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc 03d4c298-8f44-41f7-b086-96ae836152bb 2019-10-31 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc. c12f9005-a549-4447-9beb-df7126f77df1 2019-10-31 Warnings Exact identifier application number: M006 Gly-Sal 10-2 Pads SALICYLIC ACID Topiderm, Inc. b39e845d-4c40-4f9e-9cb5-a8386f326652 2019-10-23 Warnings Exact identifier application number: M006 Gly-Sal 5-2 Pads SALICYLIC ACID Topiderm, Inc. e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 2019-10-22 Warnings Exact identifier application number: M006 SKIN MEDICA Purifying Foaming Wash SALICYLIC ACID Allergan, Inc. 064d9e2b-077f-4229-b653-666fc5479ae2 2013-03-01 Warnings Exact identifier application number: M006
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