FDA.reportPublic FDA data

Anubis Barcelona

Product NDC
83021-546
11-digit product format
830210546
Labeler code
83021
Product ID
83021-546_04522475-b450-eb2f-e063-6294a90afc2b
Type
HUMAN OTC DRUG
Nonproprietary name
DMAE
Dosage form
CONCENTRATE
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2023-01-13
Marketing end
2027-08-05
Substance
GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER
Active strength
.555; .243; .09; .027; .024; .0012; .0009; .0003; .0006; .024; .45; .405; .021; 1.08; .9; .036; .15; 25.5564 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; mL/30mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-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
GLYCERIN.555 g/30mL
PHENOXYETHANOL.243 g/30mL
XANTHAN GUM.09 g/30mL
FRAGRANCE 13576.027 g/30mL
SORBITAN ISOSTEARATE.024 g/30mL
HYDROLYZED BOVINE ELASTIN (BASE.0012 g/30mL
1000 MW).0009 g/30mL
LIMONENE, (+)-.0003 g/30mL
TOCOPHEROL.0006 g/30mL
HYDROXYCITRONELLAL.024 g/30mL
POLYSORBATE 60.45 g/30mL
LECITHIN, SOYBEAN.405 g/30mL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%).021 g/30mL
DEHYDROACETIC ACID1.08 g/30mL
PROPANEDIOL.9 g/30mL
DICAPRYLYL ETHER.036 g/30mL
BENZOIC ACID.15 g/30mL
ASCORBYL GLUCOSIDE25.5564 mL/30mL
WATER

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 17 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
TTV12P4NEEInternal UNII lookup
5EM498GW35Internal UNII lookup
01S2G2C1E4Internal UNII lookup
GFD7C86Q1WInternal UNII lookup
R0ZB2556P8Internal UNII lookup
8SQ0VA4YURInternal UNII lookup
CAL22UVI4MInternal UNII lookup
1DI56QDM62Internal UNII lookup
86FQE96TZ4Internal UNII lookup
2KAG279R6RInternal UNII lookup
5965N8W85TInternal UNII lookup
77JZM5516ZInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
2V52R0NHXWInternal UNII lookup
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f22b212d-d21d-5984-e053-2995a90a683eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-546-30Anubis Barcelona30 mL in 1 BOTTLE, DROPPERCONCENTRATE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-546ANUBIS BARCELONA (DMAE) CONCENTRATE [ANUBIS COSMETICS SL]2Current NDC, 1 package rows20230902_f22b212d-d21d-5984-e053-2995a90a683e.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 35 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact identifier
application number: M016
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
application number: M016
Gelmicin Hydrocortisone with AloeHYDROCORTISONEUnited Exchange Corp.bb64eca4-799d-4711-e053-2995a90af4032025-10-21WarningsExact identifier
application number: M016
QuadrydernHYDROCORTISONEProductos Zapotol Corpa087ad4d-9a65-19c3-e053-2995a90ab3412025-10-21WarningsExact identifier
application number: M016
VENROCKROSEMARY OILGuangzhou Oupeng Cosmetics Co., Ltd4156b669-1817-6280-e063-6394a90aaf3a2025-10-17WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-546-308302105463030 mL in 1 BOTTLE, DROPPER (83021-546-30) 30 ml2023-01-132027-08-05NoNoHistorical