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 4 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact 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