FDA.reportPublic FDA data

Anubis Barcelona

Product NDC
83021-553
11-digit product format
830210553
Labeler code
83021
Product ID
83021-553_045252bb-c4ae-54e9-e063-6394a90aba06
Type
HUMAN OTC DRUG
Nonproprietary name
DMAE, ZIRHAFIRM
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2023-01-13
Marketing end
2028-03-06
Substance
ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER
Active strength
5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; mL/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [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
ALOE VERA LEAF5.988 g/60mL
LINALOOL, (+/-)-.0006 g/60mL
EUGENOL.0006 g/60mL
PROPANEDIOL2.496 g/60mL
BENZYL ALCOHOL.456 g/60mL
CETOSTEARYL ALCOHOL1.2 g/60mL
DICAPRYLYL ETHER1.5 g/60mL
SORBIC ACID.024 g/60mL
XANTHAN GUM.18 g/60mL
.BETA.-CITRONELLOL, (R)-.0006 g/60mL
GLYCERYL MONOSTEARATE2.4 g/60mL
FRAGRANCE 13576.114 g/60mL
SALICYLIC ACID.09 g/60mL
JUJUBE SEED.048 g/60mL
LECITHIN, SOYBEAN.036 g/60mL
BAICALIN.012 g/60mL
LEUZEA CARTHAMOIDES ROOT.012 g/60mL
WATER33.2616 mL/60mL
LIMONENE, (+)-.006 g/60mL
HYDROXYCITRONELLAL.0024 g/60mL
TOCOPHEROL.0018 g/60mL
GLYCERIN3.036 g/60mL
DECYL OLEATE3.9 g/60mL
SHEA BUTTER2.1 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZY81Z83H0XInternal UNII lookup
D81QY6I88EInternal UNII lookup
3T8H1794QWInternal UNII lookup
5965N8W85TInternal UNII lookup
LKG8494WBHInternal UNII lookup
2DMT128M1SInternal UNII lookup
77JZM5516ZInternal UNII lookup
X045WJ989BInternal UNII lookup
TTV12P4NEEInternal UNII lookup
P01OUT964KInternal UNII lookup
230OU9XXE4Internal UNII lookup
5EM498GW35Internal UNII lookup
O414PZ4LPZInternal UNII lookup
I51YGQ1Q2LInternal UNII lookup
1DI56QDM62Internal UNII lookup
347Q89U4M5Internal UNII lookup
P8CUH2KYHLInternal UNII lookup
059QF0KO0RInternal UNII lookup
GFD7C86Q1WInternal UNII lookup
8SQ0VA4YURInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2274f8c-08aa-eb02-e053-2a95a90a3998Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-553-60Anubis Barcelona60 mL in 1 JARCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-553ANUBIS BARCELONA (DMAE, ZIRHAFIRM) CREAM [ANUBIS COSMETICS SL]2Current NDC, 1 package rows20230902_f2274f8c-08aa-eb02-e053-2a95a90a3998.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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-553-608302105536060 mL in 1 JAR (83021-553-60) 60 ml2023-01-132028-03-06NoNoHistorical