FDA.reportPublic FDA data

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
IngredientStrength
ALCOHOL3.512 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
WATER6.2503117 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.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup
7YC686GQ8FInternal UNII lookup
3NY3SM6B8UInternal UNII lookup
6DC9Q167V3Internal UNII lookup
597E9BI3Z3Internal UNII lookup
344S277G0ZInternal UNII lookup
SMD1X3XO9MInternal UNII lookup
Z8IX2SC1OHInternal UNII lookup
R0ZB2556P8Internal UNII lookup
5EM498GW35Internal UNII lookup
14255EXE39Internal UNII lookup
QN83US2B0NInternal UNII lookup
059QF0KO0RInternal UNII lookup
S0FAJ1R9CDInternal UNII lookup
24WE03BX2TInternal UNII lookup
T4V6TWG28DInternal UNII lookup
ND2M416302Internal UNII lookup
EB41QIU6JLInternal UNII lookup
A2I8C7HI9TInternal UNII lookup
WV9CM0O67ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb905bd0-c600-b8b2-e053-2995a90ad259Available on FDA.report

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

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 54 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
ndc (product): 83021-624
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
application number: M006
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
application number: M006
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
application number: M006
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
application number: M006
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
application number: M006

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