FDA.reportPublic FDA data

Anubis Barcelona

Product NDC
83021-617
11-digit product format
830210617
Labeler code
83021
Product ID
83021-617_045252bb-c4b5-54e9-e063-6394a90aba06
Type
HUMAN OTC DRUG
Nonproprietary name
Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Allantoin
Dosage form
CONCENTRATE
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-21
Marketing end
2027-09-20
Substance
PROPYLPARABEN; ALLANTOIN; PANTHENOL; FD&C YELLOW NO. 5; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; METHYLPARABEN; TIOXOLONE; WATER; ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; ASCORBYL PALMITATE; RIBOFLAVIN; ETHYLPARABEN; TOCOPHEROL; CITRAL; LIMONENE, (+)-; POWDERED CELLULOSE; ISOPROPYL ALCOHOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; LEVOMENOL; FARNESOL; FRAGRANCE 13576; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE
Active strength
.0000001; .0125; .0025; .00001; .0069; .000035; .00500065; .01; 3.12515585; 1.756; .02; .01725; .00005; .000003; .00000015; .000001; .000097; .002095; .0003; .0006; .017; .0045; .0005; .01; .000003; .00000025; .0001 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; mL/5mL; mL/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPYLPARABEN.0000001 g/5mL
ALLANTOIN.0125 g/5mL
PANTHENOL.0025 g/5mL
FD&C YELLOW NO. 5.00001 g/5mL
PROPYLENE GLYCOL.0069 g/5mL
ARCTIUM LAPPA ROOT.000035 g/5mL
METHYLPARABEN.00500065 g/5mL
TIOXOLONE.01 g/5mL
WATER3.12515585 mL/5mL
ALCOHOL1.756 mL/5mL
POLYOXYL 40 HYDROGENATED CASTOR OIL.02 g/5mL
YEAST, UNSPECIFIED.01725 g/5mL
ASCORBYL PALMITATE.00005 g/5mL
RIBOFLAVIN.000003 g/5mL
ETHYLPARABEN.00000015 g/5mL
TOCOPHEROL.000001 g/5mL
CITRAL.000097 g/5mL
LIMONENE, (+)-.002095 g/5mL
POWDERED CELLULOSE.0003 g/5mL
ISOPROPYL ALCOHOL.0006 g/5mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.017 g/5mL
LEVOMENOL.0045 g/5mL
FARNESOL.0005 g/5mL
FRAGRANCE 13576.01 g/5mL
PHENOXYETHANOL.000003 g/5mL
BUTYLPARABEN.00000025 g/5mL
NIACINAMIDE.0001 g/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 27 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z8IX2SC1OHInternal UNII lookup
344S277G0ZInternal UNII lookup
WV9CM0O67ZInternal UNII lookup
I753WB2F1MInternal UNII lookup
6DC9Q167V3Internal UNII lookup
597E9BI3Z3Internal UNII lookup
A2I8C7HI9TInternal UNII lookup
S0FAJ1R9CDInternal UNII lookup
059QF0KO0RInternal UNII lookup
3K9958V90MInternal UNII lookup
7YC686GQ8FInternal UNII lookup
3NY3SM6B8UInternal UNII lookup
QN83US2B0NInternal UNII lookup
TLM2976OFRInternal UNII lookup
14255EXE39Internal UNII lookup
R0ZB2556P8Internal UNII lookup
T7EU0O9VPPInternal UNII lookup
GFD7C86Q1WInternal UNII lookup
SMD1X3XO9MInternal UNII lookup
ND2M416302Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb9244ea-6102-3cbe-e053-2a95a90ab8f6Available 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
83021-617-05Anubis Barcelona5 mL in 1 VIAL, GLASSCONCENTRATE52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-617ANUBIS BARCELONA (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN) CONCENTRATE [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb9244ea-6102-3cbe-e053-2a95a90ab8f6.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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony 10% SulfurSULFURD3 Development, Inc.c78ead80-a8ee-0b52-e053-2a95a90ab8802025-12-01WarningsExact identifier
application number: M006
Dermaharmony 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDOars And Alps LLCefe14f46-c947-aea4-e053-2a95a90aad5f2025-12-01WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-617-05830210617055 mL in 1 VIAL, GLASS (83021-617-05) 5 ml2022-10-212027-09-20NoNoCurrent