FDA.reportPublic FDA data

Anubis Barcelona

Product NDC
83021-495
11-digit product format
830210495
Labeler code
83021
Product ID
83021-495_045289e2-7a73-8d91-e063-6394a90ab123
Type
HUMAN OTC DRUG
Nonproprietary name
Proteoglycan, Glycerin, Butylene Glycol
Dosage form
CONCENTRATE
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-25
Marketing end
2027-09-02
Substance
PHENOXYETHANOL; XANTHAN GUM; BENZOIC ACID; WATER; BUTYLENE GLYCOL; PROPANEDIOL; POLYSORBATE 20; EDETIC ACID; PROTEOGLYCAN 4; FRAGRANCE 13576; GLYCERIN; DEHYDROACETIC ACID
Active strength
.162; .08; .024; 16.4578; .46; .4; .2; .0002; .002; .03; 2; .014 g/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL
Pharmacologic classes
Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-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
PHENOXYETHANOL.162 g/20mL
XANTHAN GUM.08 g/20mL
BENZOIC ACID.024 g/20mL
WATER16.4578 mL/20mL
BUTYLENE GLYCOL.46 g/20mL
PROPANEDIOL.4 g/20mL
POLYSORBATE 20.2 g/20mL
EDETIC ACID.0002 g/20mL
PROTEOGLYCAN 4.002 g/20mL
FRAGRANCE 13576.03 g/20mL
GLYCERIN2 g/20mL
DEHYDROACETIC ACID.014 g/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HIE492ZZ3TInternal UNII lookup
TTV12P4NEEInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
059QF0KO0RInternal UNII lookup
3XUS85K0RAInternal UNII lookup
5965N8W85TInternal UNII lookup
7T1F30V5YHInternal UNII lookup
9G34HU7RV0Internal UNII lookup
M65IE9C8XJInternal UNII lookup
5EM498GW35Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
2KAG279R6RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebdddcec-f5da-51fe-e053-2995a90a6167Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-495-20Anubis Barcelona20 mL in 1 BOTTLE, DROPPERCONCENTRATE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-495ANUBIS BARCELONA (PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL) CONCENTRATE [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_ebdddcec-f5da-51fe-e053-2995a90a6167.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-495-208302104952020 mL in 1 BOTTLE, DROPPER (83021-495-20) 20 ml2022-10-252027-09-02NoNoCurrent