Home NDC 83021-300 Anubis Barcelona Regul Oil
Product NDC 83021-300
11-digit product format 830210300
Labeler code 83021
Product ID 83021-300_0452aac5-a076-8ea7-e063-6394a90a7c02
Type HUMAN OTC DRUG
Nonproprietary name Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (Hops) Cone Extract
Dosage form CREAM
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M006
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-10-20
Marketing end 2028-02-03
Substance ARCTIUM LAPPA ROOT; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); LAURETH-7; PEG/PPG-20/6 DIMETHICONE; ALCOHOL; GLYCERIN; CETEARYL ETHYLHEXANOATE; LIMONENE, (+)-; PANTHENOL; IMIDUREA; FD&C YELLOW NO. 5; RIBOFLAVIN; PHENOXYETHANOL; FRAGRANCE 13576; WATER; CETOSTEARYL ALCOHOL; PROPYLENE GLYCOL; MINERAL OIL; ETHYLHEXYLGLYCERIN; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; HOPS; TIOXOLONE; PROPYLPARABEN; YEAST, UNSPECIFIED; NIACINAMIDE; C13-14 ISOPARAFFIN; METHYLPARABEN; GLYCERYL STEARATE SE; TRIISOPROPANOLAMINE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
Active strength .012; .8; .12; 1.372; .08; .048; 4; .08398; .1; .6; .00004; .00012; .0252; .6; 123.55598; 26; 10.148; 6; .0028; .045; .15; .0012; .3; .24; .023; .023; .48; .48; 7; .004; .0012 g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL
Pharmacologic classes Allergens [CS], Allergens [CS], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], 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 ARCTIUM LAPPA ROOT .012 g/200mL POLYACRYLAMIDE (CROSSLINKED .8 g/200mL 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) .12 g/200mL LAURETH-7 1.372 g/200mL PEG/PPG-20/6 DIMETHICONE .08 mL/200mL ALCOHOL .048 g/200mL GLYCERIN 4 g/200mL CETEARYL ETHYLHEXANOATE .08398 g/200mL LIMONENE, (+)- .1 g/200mL PANTHENOL .6 g/200mL IMIDUREA .00004 g/200mL FD&C YELLOW NO. 5 .00012 g/200mL RIBOFLAVIN .0252 g/200mL PHENOXYETHANOL .6 g/200mL FRAGRANCE 13576 123.55598 mL/200mL WATER 26 g/200mL CETOSTEARYL ALCOHOL 10.148 g/200mL PROPYLENE GLYCOL 6 g/200mL MINERAL OIL .0028 g/200mL ETHYLHEXYLGLYCERIN .045 g/200mL METHYLCHLOROISOTHIAZOLINONE .15 g/200mL METHYLISOTHIAZOLINONE .0012 g/200mL HOPS .3 g/200mL TIOXOLONE .24 g/200mL PROPYLPARABEN .023 g/200mL YEAST, UNSPECIFIED .023 g/200mL NIACINAMIDE .48 g/200mL C13-14 ISOPARAFFIN .48 g/200mL METHYLPARABEN 7 g/200mL GLYCERYL STEARATE SE .004 g/200mL TRIISOPROPANOLAMINE .0012 g/200mL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 30 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 83021-300-01 Anubis Barcelona Regul Oil 200 mL in 1 TUBE CREAM 200 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-300 ANUBIS BARCELONA REGUL OIL (PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT) CREAM [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230902_eb7c418b-8bee-26a3-e053-2a95a90a4e96.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 7 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 83021-300-01 83021030001 200 mL in 1 TUBE (83021-300-01) 200 ml 2022-10-20 2028-02-03 No No Current