Home NDC 83021-624 Anubis Barcelona Regul OIl
Product NDC 83021-624
11-digit product format 830210624
Labeler code 83021
Product ID 83021-624_0452a0dd-b516-29ea-e063-6294a90aecca
Type HUMAN OTC DRUG
Nonproprietary name Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract
Dosage form CONCENTRATE
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M006
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-10-21
Marketing end 2027-07-07
Substance ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; ALLANTOIN; POWDERED CELLULOSE; PROPYLPARABEN; TOCOPHEROL; FRAGRANCE 13576; ETHYLPARABEN; ASCORBYL PALMITATE; WATER; TIOXOLONE; LEVOMENOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; FARNESOL; METHYLPARABEN; PANTHENOL; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE; RIBOFLAVIN; CITRAL; LIMONENE, (+)-; FD&C YELLOW NO. 5
Active strength 3.512; .04; .0345; .0138; .00007; .025; .0006; .0000002; .000002; .02; .0000003; .0001; 6.2503117; .02; .009; .034; .0012; .001; .0100013; .005; .000006; .0000005; .0002; .000006; .000194; .00419; .00002 mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL
Pharmacologic classes Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [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 Regul OIl Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 3.512 mL/10mL POLYOXYL 40 HYDROGENATED CASTOR OIL .04 g/10mL YEAST, UNSPECIFIED .0345 g/10mL PROPYLENE GLYCOL .0138 g/10mL ARCTIUM LAPPA ROOT .00007 g/10mL ALLANTOIN .025 g/10mL POWDERED CELLULOSE .0006 g/10mL PROPYLPARABEN .0000002 g/10mL TOCOPHEROL .000002 g/10mL FRAGRANCE 13576 .02 g/10mL ETHYLPARABEN .0000003 g/10mL ASCORBYL PALMITATE .0001 g/10mL WATER 6.2503117 mL/10mL TIOXOLONE .02 g/10mL LEVOMENOL .009 g/10mL HYDROXYETHYL CELLULOSE, UNSPECIFIED .034 g/10mL ISOPROPYL ALCOHOL .0012 g/10mL FARNESOL .001 g/10mL METHYLPARABEN .0100013 g/10mL PANTHENOL .005 g/10mL PHENOXYETHANOL .000006 g/10mL BUTYLPARABEN .0000005 g/10mL NIACINAMIDE .0002 g/10mL RIBOFLAVIN .000006 g/10mL CITRAL .000194 g/10mL LIMONENE, (+)- .00419 g/10mL FD&C YELLOW NO. 5 .00002 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 27 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 83021-624-10 Anubis Barcelona Regul OIl 10 mL in 1 BOTTLE, WITH APPLICATOR CONCENTRATE 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-624 ANUBIS BARCELONA REGUL OIL (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT) CONCENTRATE [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230902_eb905bd0-c600-b8b2-e053-2995a90ad259.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 22 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 83021-624-10 83021062410 10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10) 10 ml 2022-10-21 2027-07-07 No No Current