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; ALLANTOIN; ARCTIUM LAPPA ROOT; ASCORBYL PALMITATE; BUTYLPARABEN; CITRAL; ETHYLPARABEN; FARNESOL; FD&C YELLOW NO. 5; FRAGRANCE 13576; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; LEVOMENOL; LIMONENE, (+)-; METHYLPARABEN; NIACINAMIDE; PANTHENOL; PHENOXYETHANOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; POWDERED CELLULOSE; PROPYLENE GLYCOL; PROPYLPARABEN; RIBOFLAVIN; TIOXOLONE; TOCOPHEROL; WATER; YEAST, UNSPECIFIED
Active strength
3.512; .025; .00007; .0001; .0000005; .000194; .0000003; .001; .00002; .02; .034; .0012; .009; .00419; .0100013; .0002; .005; .000006; .04; .0006; .0138; .0000002; .000006; .02; .000002; 6.2503117; .0345 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; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; mL/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

Additional Listing Data#

Finished product
Yes
Brand name base
Anubis Barcelona Regul OIl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL3.512 mL/10mL
ALLANTOIN.025 g/10mL
ARCTIUM LAPPA ROOT.00007 g/10mL
ASCORBYL PALMITATE.0001 g/10mL
BUTYLPARABEN.0000005 g/10mL
CITRAL.000194 g/10mL
ETHYLPARABEN.0000003 g/10mL
FARNESOL.001 g/10mL
FD&C YELLOW NO. 5.00002 g/10mL
FRAGRANCE 13576.02 g/10mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.034 g/10mL
ISOPROPYL ALCOHOL.0012 g/10mL
LEVOMENOL.009 g/10mL
LIMONENE, (+)-.00419 g/10mL
METHYLPARABEN.0100013 g/10mL
NIACINAMIDE.0002 g/10mL
PANTHENOL.005 g/10mL
PHENOXYETHANOL.000006 g/10mL
POLYOXYL 40 HYDROGENATED CASTOR OIL.04 g/10mL
POWDERED CELLULOSE.0006 g/10mL
PROPYLENE GLYCOL.0138 g/10mL
PROPYLPARABEN.0000002 g/10mL
RIBOFLAVIN.000006 g/10mL
TIOXOLONE.02 g/10mL
TOCOPHEROL.000002 g/10mL
WATER6.2503117 mL/10mL
YEAST, UNSPECIFIED.0345 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M, 344S277G0Z, 597E9BI3Z3, QN83US2B0N, 3QPI1U3FV8, T7EU0O9VPP, 14255EXE39, EB41QIU6JL, I753WB2F1M, 5EM498GW35, T4V6TWG28D, ND2M416302, 24WE03BX2T, GFD7C86Q1W, A2I8C7HI9T, 25X51I8RD4, WV9CM0O67Z, HIE492ZZ3T, 7YC686GQ8F, SMD1X3XO9M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-624-10Anubis Barcelona Regul OIl10 mL in 1 BOTTLE, WITH APPLICATORCONCENTRATE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-624ANUBIS BARCELONA REGUL OIL (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT) CONCENTRATE [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb905bd0-c600-b8b2-e053-2995a90ad259.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-624-108302106241010 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10) 10 ml2022-10-212027-07-07NoNoCurrent