FDA.reportPublic FDA data

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
GLYCERIN; GERANIOL; ISOPROPYL ALCOHOL; ALCOHOL; OXYBENZONE; PHENOXYETHANOL; TEA TREE OIL; IMIDUREA; WATER; GLYCERYL STEARATE SE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; TIOXOLONE; LINALOOL, (+/-)-; FD&C YELLOW NO. 5; BENZYL BENZOATE; PANTHENOL; COUMARIN; C12-20 ACID PEG-8 ESTER; ARCTIUM LAPPA ROOT; PROPYLPARABEN; CETYL ALCOHOL; YEAST, UNSPECIFIED; RIBOFLAVIN; PROPYLENE GLYCOL; CETEARYL ETHYLHEXANOATE; HYDROXYETHYL CELLULOSE, UNSPECIFIED; BUTYLATED HYDROXYTOLUENE; CITRAL; GREEN TEA LEAF; ALLANTOIN; LIMONENE, (+)-; NIACINAMIDE; POWDERED CELLULOSE; POLYOXYL 40 HYDROGENATED CASTOR OIL; .ALPHA.-HEXYLCINNAMALDEHYDE; OCTINOXATE; METHYLPARABEN; FRAGRANCE 13576
Active strength
.08784; .003398; .002132; 3.5436; 1.6; 1.3; .1; .4; 155.839258; 6; .8; .3; .026404; .01044; .004; .04; .003924; 4; .003512; .28; .015; .1; .00012; 6.469044; 10; .12863; .104; .01032; .00679; .2; .061818; .02; .001066; 1.8; .00574; 3.996; .6; .5 g/200mL; g/200mL; g/200mL; mL/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; 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], 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

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
GLYCERIN.08784 g/200mL
GERANIOL.003398 g/200mL
ISOPROPYL ALCOHOL.002132 g/200mL
ALCOHOL3.5436 mL/200mL
OXYBENZONE1.6 g/200mL
PHENOXYETHANOL1.3 g/200mL
TEA TREE OIL.1 g/200mL
IMIDUREA.4 g/200mL
WATER155.839258 mL/200mL
GLYCERYL STEARATE SE6 g/200mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.8 g/200mL
TIOXOLONE.3 g/200mL
LINALOOL, (+/-)-.026404 g/200mL
FD&C YELLOW NO. 5.01044 g/200mL
BENZYL BENZOATE.004 g/200mL
PANTHENOL.04 g/200mL
COUMARIN.003924 g/200mL
C12-20 ACID PEG-8 ESTER4 g/200mL
ARCTIUM LAPPA ROOT.003512 g/200mL
PROPYLPARABEN.28 g/200mL
CETYL ALCOHOL.015 g/200mL
YEAST, UNSPECIFIED.1 g/200mL
RIBOFLAVIN.00012 g/200mL
PROPYLENE GLYCOL6.469044 g/200mL
CETEARYL ETHYLHEXANOATE10 g/200mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.12863 g/200mL
BUTYLATED HYDROXYTOLUENE.104 g/200mL
CITRAL.01032 g/200mL
GREEN TEA LEAF.00679 g/200mL
ALLANTOIN.2 g/200mL
LIMONENE, (+)-.061818 g/200mL
NIACINAMIDE.02 g/200mL
POWDERED CELLULOSE.001066 g/200mL
POLYOXYL 40 HYDROGENATED CASTOR OIL1.8 g/200mL
.ALPHA.-HEXYLCINNAMALDEHYDE.00574 g/200mL
OCTINOXATE3.996 g/200mL
METHYLPARABEN.6 g/200mL
FRAGRANCE 13576.5 g/200mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 38 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
L837108USYInternal UNII lookup
ND2M416302Internal UNII lookup
3K9958V90MInternal UNII lookup
95OOS7VE0YInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
VIF565UC2GInternal UNII lookup
M629807ATLInternal UNII lookup
059QF0KO0RInternal UNII lookup
FCZ5MH785IInternal UNII lookup
0A5MM307FCInternal UNII lookup
S0FAJ1R9CDInternal UNII lookup
D81QY6I88EInternal UNII lookup
I753WB2F1MInternal UNII lookup
N863NB338GInternal UNII lookup
WV9CM0O67ZInternal UNII lookup
A4VZ22K1WTInternal UNII lookup
9M7A3K4339Internal UNII lookup
597E9BI3Z3Internal UNII lookup
Z8IX2SC1OHInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb68c3ab-7835-1a1c-e053-2995a90a0d66Available 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
83021-742-01Anubis 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

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 12 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
application number: M006
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
application number: M006
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact identifier
application number: M006

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