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
ALCOHOL; ARCTIUM LAPPA ROOT; C13-14 ISOPARAFFIN; CETEARYL ETHYLHEXANOATE; CETOSTEARYL ALCOHOL; ETHYLHEXYLGLYCERIN; FD&C YELLOW NO. 5; FRAGRANCE 13576; GLYCERIN; GLYCERYL STEARATE SE; HOPS; IMIDUREA; LAURETH-7; LIMONENE, (+)-; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; METHYLPARABEN; MINERAL OIL; NIACINAMIDE; PANTHENOL; PEG/PPG-20/6 DIMETHICONE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE); PHENOXYETHANOL; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); PROPYLENE GLYCOL; PROPYLPARABEN; RIBOFLAVIN; TIOXOLONE; TRIISOPROPANOLAMINE; WATER; YEAST, UNSPECIFIED
Active strength
.08; .012; .48; 4; 26; .0028; .00004; .6; .048; 7; .0012; .6; .12; .08398; .045; .15; .48; 6; .023; .1; 1.372; .0012; .0252; .8; 10.148; .24; .00012; .3; .004; 123.55598; .023 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; mL/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

Additional Listing Data#

Finished product
Yes
Brand name base
Anubis Barcelona Regul Oil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.08 mL/200mL
ARCTIUM LAPPA ROOT.012 g/200mL
C13-14 ISOPARAFFIN.48 g/200mL
CETEARYL ETHYLHEXANOATE4 g/200mL
CETOSTEARYL ALCOHOL26 g/200mL
ETHYLHEXYLGLYCERIN.0028 g/200mL
FD&C YELLOW NO. 5.00004 g/200mL
FRAGRANCE 13576.6 g/200mL
GLYCERIN.048 g/200mL
GLYCERYL STEARATE SE7 g/200mL
HOPS.0012 g/200mL
IMIDUREA.6 g/200mL
LAURETH-7.12 g/200mL
LIMONENE, (+)-.08398 g/200mL
METHYLCHLOROISOTHIAZOLINONE.045 g/200mL
METHYLISOTHIAZOLINONE.15 g/200mL
METHYLPARABEN.48 g/200mL
MINERAL OIL6 g/200mL
NIACINAMIDE.023 g/200mL
PANTHENOL.1 g/200mL
PEG/PPG-20/6 DIMETHICONE1.372 g/200mL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE).0012 g/200mL
PHENOXYETHANOL.0252 g/200mL
POLYACRYLAMIDE (CROSSLINKED.8 g/200mL
0.01-0.2 MOLE PERCENT BISACRYLAMIDE)10.148 g/200mL
PROPYLENE GLYCOL.24 g/200mL
PROPYLPARABEN.00012 g/200mL
RIBOFLAVIN.3 g/200mL
TIOXOLONE.004 g/200mL
TRIISOPROPANOLAMINE123.55598 mL/200mL
WATER.023 g/200mL
YEAST, UNSPECIFIED

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M, 597E9BI3Z3, E4F12ROE70, 9M64UO4C25, 2DMT128M1S, 147D247K3P, I753WB2F1M, 5EM498GW35, PDC6A3C0OX, FCZ5MH785I, 01G73H6H83, M629807ATL, Z95S6G8201, GFD7C86Q1W, DEL7T5QRPN, 229D0E1QFA, A2I8C7HI9T, T5L8T28FGP, 25X51I8RD4, WV9CM0O67Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-300-01Anubis Barcelona Regul Oil200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-300ANUBIS BARCELONA REGUL OIL (PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb7c418b-8bee-26a3-e053-2a95a90a4e96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-300-0183021030001200 mL in 1 TUBE (83021-300-01) 200 ml2022-10-202028-02-03NoNoCurrent