Anubis Barcelona Regul Oil

Product NDC
83021-742
11-digit product format
830210742
Labeler code
83021
Product ID
83021-742_04529ef6-e358-95c2-e063-6394a90ae70d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetearyl Ethylhexanoate, Propylene Glycol, Glyceryl Stearate Se
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-19
Marketing end
2027-02-20
Substance
.ALPHA.-HEXYLCINNAMALDEHYDE; ALCOHOL; ALLANTOIN; ARCTIUM LAPPA ROOT; BENZYL BENZOATE; BUTYLATED HYDROXYTOLUENE; C12-20 ACID PEG-8 ESTER; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CETEARYL ETHYLHEXANOATE; CETYL ALCOHOL; CITRAL; COUMARIN; FD&C YELLOW NO. 5; FRAGRANCE 13576; GERANIOL; GLYCERIN; GLYCERYL STEARATE SE; GREEN TEA LEAF; HYDROXYETHYL CELLULOSE, UNSPECIFIED; IMIDUREA; ISOPROPYL ALCOHOL; LIMONENE, (+)-; LINALOOL, (+/-)-; METHYLPARABEN; NIACINAMIDE; OCTINOXATE; OXYBENZONE; PANTHENOL; PHENOXYETHANOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; POWDERED CELLULOSE; PROPYLENE GLYCOL; PROPYLPARABEN; RIBOFLAVIN; TEA TREE OIL; TIOXOLONE; WATER; YEAST, UNSPECIFIED
Active strength
.00574; 3.5436; .2; .003512; .004; .104; 4; .8; 10; .015; .01032; .003924; .01044; .5; .003398; .08784; 6; .00679; .12863; .4; .002132; .061818; .026404; .6; .02; 3.996; 1.6; .04; 1.3; 1.8; .001066; 6.469044; .28; .00012; .1; .3; 155.839258; .1 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; 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; g/200mL; g/200mL; mL/200mL; g/200mL
Pharmacologic classes
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], Dietary Proteins [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 IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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
.ALPHA.-HEXYLCINNAMALDEHYDE.00574 g/200mL
ALCOHOL3.5436 mL/200mL
ALLANTOIN.2 g/200mL
ARCTIUM LAPPA ROOT.003512 g/200mL
BENZYL BENZOATE.004 g/200mL
BUTYLATED HYDROXYTOLUENE.104 g/200mL
C12-20 ACID PEG-8 ESTER4 g/200mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.8 g/200mL
CETEARYL ETHYLHEXANOATE10 g/200mL
CETYL ALCOHOL.015 g/200mL
CITRAL.01032 g/200mL
COUMARIN.003924 g/200mL
FD&C YELLOW NO. 5.01044 g/200mL
FRAGRANCE 13576.5 g/200mL
GERANIOL.003398 g/200mL
GLYCERIN.08784 g/200mL
GLYCERYL STEARATE SE6 g/200mL
GREEN TEA LEAF.00679 g/200mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.12863 g/200mL
IMIDUREA.4 g/200mL
ISOPROPYL ALCOHOL.002132 g/200mL
LIMONENE, (+)-.061818 g/200mL
LINALOOL, (+/-)-.026404 g/200mL
METHYLPARABEN.6 g/200mL
NIACINAMIDE.02 g/200mL
OCTINOXATE3.996 g/200mL
OXYBENZONE1.6 g/200mL
PANTHENOL.04 g/200mL
PHENOXYETHANOL1.3 g/200mL
POLYOXYL 40 HYDROGENATED CASTOR OIL1.8 g/200mL
POWDERED CELLULOSE.001066 g/200mL
PROPYLENE GLYCOL6.469044 g/200mL
PROPYLPARABEN.28 g/200mL
RIBOFLAVIN.00012 g/200mL
TEA TREE OIL.1 g/200mL
TIOXOLONE.3 g/200mL
WATER155.839258 mL/200mL
YEAST, UNSPECIFIED.1 g/200mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7X6O37OK2I, 3K9958V90M, 344S277G0Z, 597E9BI3Z3, N863NB338G, 1P9D0Z171K, 9M7A3K4339, 0A5MM307FC, 9M64UO4C25, 936JST6JCN, T7EU0O9VPP, A4VZ22K1WT, I753WB2F1M, 5EM498GW35, L837108USY, PDC6A3C0OX, FCZ5MH785I, W2ZU1RY8B0, T4V6TWG28D, M629807ATL

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
83021-742-01Anubis Barcelona Regul Oil200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-742ANUBIS BARCELONA REGUL OIL (CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb68c3ab-7835-1a1c-e053-2995a90a0d66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-742-0183021074201200 mL in 1 TUBE (83021-742-01) 200 ml2022-10-192027-02-20NoNoCurrent