Home NDC 83021-553 Anubis Barcelona
Product NDC 83021-553
11-digit product format 830210553
Labeler code 83021
Product ID 83021-553_045252bb-c4ae-54e9-e063-6394a90aba06
Type HUMAN OTC DRUG
Nonproprietary name DMAE, ZIRHAFIRM
Dosage form CREAM
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M016
Marketing category OTC MONOGRAPH FINAL
Marketing start 2023-01-13
Marketing end 2028-03-06
Substance ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER
Active strength 5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; mL/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL
Pharmacologic classes Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], 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 ALOE VERA LEAF 5.988 g/60mL LINALOOL, (+/-)- .0006 g/60mL EUGENOL .0006 g/60mL PROPANEDIOL 2.496 g/60mL BENZYL ALCOHOL .456 g/60mL CETOSTEARYL ALCOHOL 1.2 g/60mL DICAPRYLYL ETHER 1.5 g/60mL SORBIC ACID .024 g/60mL XANTHAN GUM .18 g/60mL .BETA.-CITRONELLOL, (R)- .0006 g/60mL GLYCERYL MONOSTEARATE 2.4 g/60mL FRAGRANCE 13576 .114 g/60mL SALICYLIC ACID .09 g/60mL JUJUBE SEED .048 g/60mL LECITHIN, SOYBEAN .036 g/60mL BAICALIN .012 g/60mL LEUZEA CARTHAMOIDES ROOT .012 g/60mL WATER 33.2616 mL/60mL LIMONENE, (+)- .006 g/60mL HYDROXYCITRONELLAL .0024 g/60mL TOCOPHEROL .0018 g/60mL GLYCERIN 3.036 g/60mL DECYL OLEATE 3.9 g/60mL SHEA BUTTER 2.1 g/60mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 24 matching rows.
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 83021-553-60 Anubis Barcelona 60 mL in 1 JAR CREAM 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-553 ANUBIS BARCELONA (DMAE, ZIRHAFIRM) CREAM [ANUBIS COSMETICS SL] 2 Current NDC, 1 package rows 20230902_f2274f8c-08aa-eb02-e053-2a95a90a3998.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 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 83021-553-60 83021055360 60 mL in 1 JAR (83021-553-60) 60 ml 2023-01-13 2028-03-06 No No Historical