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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact 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