FDA.reportPublic FDA data

Anubis Barcelona Vital Line

Product NDC
83021-187
11-digit product format
830210187
Labeler code
83021
Product ID
83021-187_ebe024f7-7c46-ad60-e053-2995a90a45d6
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-25
Marketing end
0000-00-00
Substance
.ALPHA.-HEXYLCINNAMALDEHYDE; .BETA.-CITRONELLOL, (R)-; AVOBENZONE; BENZOIC ACID; BUTYLATED HYDROXYTOLUENE; CENTAUREA CYANUS FLOWER; CETOSTEARYL ALCOHOL; CETYL ALCOHOL; COCO-GLYCERIDES; DEHYDROACETIC ACID; FRAGRANCE 13576; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); ISOMETHYL-.ALPHA.-IONONE; LIMONENE, (+)-; MEDIUM-CHAIN TRIGLYCERIDES; OCTINOXATE; PHENOXYETHANOL; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; VIOLA ODORATA; WATER
Active strength
0 g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL
Pharmacologic classes
Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Vital Line

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/200mL
PHENOXYETHANOL1.62 g/200mL
FRAGRANCE 13576.98 g/200mL
DEHYDROACETIC ACID.14 g/200mL
HYDROLYZED BOVINE ELASTIN (BASE.03 g/200mL
1000 MW)5 g/200mL
OCTINOXATE8 g/200mL
COCO-GLYCERIDES6.94 g/200mL
GLYCERIN.6 g/200mL
HYDROLYSED MARINE COLLAGEN (ENZYMATIC12.58 g/200mL
2000 MW)12 g/200mL
CETOSTEARYL ALCOHOL4 g/200mL
MEDIUM-CHAIN TRIGLYCERIDES.16 g/200mL
CETYL ALCOHOL140 mL/200mL
.ALPHA.-HEXYLCINNAMALDEHYDE.24 g/200mL
WATER.05 g/200mL
BENZOIC ACID.05 g/200mL
CENTAUREA CYANUS FLOWER.038 g/200mL
VIOLA ODORATA.006 g/200mL
LIMONENE, (+)-.0056 g/200mL
POTASSIUM PHOSPHATE, UNSPECIFIED FORM.0054 g/200mL
.BETA.-CITRONELLOL, (R)-.005 g/200mL
ISOMETHYL-.ALPHA.-IONONE
BUTYLATED HYDROXYTOLUENE

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
5EM498GW35Internal UNII lookup
2KAG279R6RInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
ISE9I7DNUGInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
2DMT128M1SInternal UNII lookup
C9H2L21V7UInternal UNII lookup
936JST6JCNInternal UNII lookup
7X6O37OK2IInternal UNII lookup
059QF0KO0RInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
QZ239038YCInternal UNII lookup
AET12U8B74Internal UNII lookup
GFD7C86Q1WInternal UNII lookup
B7862WZ632Internal UNII lookup
P01OUT964KInternal UNII lookup
9XP4LC555BInternal UNII lookup
1P9D0Z171KInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebe024f7-7c45-ad60-e053-2995a90a45d6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-187-01Anubis Barcelona Vital Line200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-187ANUBIS BARCELONA VITAL LINE (HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES) CREAM [ANUBIS COSMETICS SL]2Legacy NDC, 1 package rows20230902_ebe024f7-7c45-ad60-e053-2995a90a45d6.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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-187-0183021018701200 mL in 1 TUBE (83021-187-01) 200 ml2022-10-250000-00-00NoNoCurrent