Home NDC 83021-546 Anubis Barcelona
Product NDC 83021-546
11-digit product format 830210546
Labeler code 83021
Product ID 83021-546_04522475-b450-eb2f-e063-6294a90afc2b
Type HUMAN OTC DRUG
Nonproprietary name DMAE
Dosage form CONCENTRATE
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M016
Marketing category OTC MONOGRAPH FINAL
Marketing start 2023-01-13
Marketing end 2027-08-05
Substance GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER
Active strength .555; .243; .09; .027; .024; .0012; .0009; .0003; .0006; .024; .45; .405; .021; 1.08; .9; .036; .15; 25.5564 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; mL/30mL
Pharmacologic classes Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
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 Anubis Barcelona Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN .555 g/30mL PHENOXYETHANOL .243 g/30mL XANTHAN GUM .09 g/30mL FRAGRANCE 13576 .027 g/30mL SORBITAN ISOSTEARATE .024 g/30mL HYDROLYZED BOVINE ELASTIN (BASE .0012 g/30mL 1000 MW) .0009 g/30mL LIMONENE, (+)- .0003 g/30mL TOCOPHEROL .0006 g/30mL HYDROXYCITRONELLAL .024 g/30mL POLYSORBATE 60 .45 g/30mL LECITHIN, SOYBEAN .405 g/30mL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) .021 g/30mL DEHYDROACETIC ACID 1.08 g/30mL PROPANEDIOL .9 g/30mL DICAPRYLYL ETHER .036 g/30mL BENZOIC ACID .15 g/30mL ASCORBYL GLUCOSIDE 25.5564 mL/30mL WATER
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 17 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 83021-546-30 Anubis Barcelona 30 mL in 1 BOTTLE, DROPPER CONCENTRATE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-546 ANUBIS BARCELONA (DMAE) CONCENTRATE [ANUBIS COSMETICS SL] 2 Current NDC, 1 package rows 20230902_f22b212d-d21d-5984-e053-2995a90a683e.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 39 of 68 · 1,350 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 83021-546-30 83021054630 30 mL in 1 BOTTLE, DROPPER (83021-546-30) 30 ml 2023-01-13 2027-08-05 No No Historical