FDA.reportPublic FDA data

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
IngredientStrength
ARCTIUM LAPPA ROOT.012 g/200mL
POLYACRYLAMIDE (CROSSLINKED.8 g/200mL
0.01-0.2 MOLE PERCENT BISACRYLAMIDE).12 g/200mL
LAURETH-71.372 g/200mL
PEG/PPG-20/6 DIMETHICONE.08 mL/200mL
ALCOHOL.048 g/200mL
GLYCERIN4 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 13576123.55598 mL/200mL
WATER26 g/200mL
CETOSTEARYL ALCOHOL10.148 g/200mL
PROPYLENE GLYCOL6 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
METHYLPARABEN7 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.

Identifier, FDA.report destination table
IdentifierFDA.report destination
597E9BI3Z3Internal UNII lookup
Z95S6G8201Internal UNII lookup
PWZ7N4UIKEInternal UNII lookup
3K9958V90MInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
9M64UO4C25Internal UNII lookup
GFD7C86Q1WInternal UNII lookup
WV9CM0O67ZInternal UNII lookup
M629807ATLInternal UNII lookup
I753WB2F1MInternal UNII lookup
TLM2976OFRInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
5EM498GW35Internal UNII lookup
059QF0KO0RInternal UNII lookup
2DMT128M1SInternal UNII lookup
6DC9Q167V3Internal UNII lookup
T5L8T28FGPInternal UNII lookup
147D247K3PInternal UNII lookup
DEL7T5QRPNInternal UNII lookup
229D0E1QFAInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb7c418b-8bee-26a3-e053-2a95a90a4e96Available 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
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

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
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
ndc (product): 83021-300
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
83021-300-0183021030001200 mL in 1 TUBE (83021-300-01) 200 ml2022-10-202028-02-03NoNoCurrent