FDA.reportPublic FDA data

AnubisMed

Product NDC
83021-401
11-digit product format
830210401
Labeler code
83021
Product ID
83021-401_049fdc9c-b52f-63c1-e063-6394a90aaa6a
Type
HUMAN OTC DRUG
Nonproprietary name
Glycolic Acid, Citric Acid, Lactic Acid, Kojic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-04
Marketing end
2027-07-01
Substance
GLYCOLIC ACID; KOJIC ACID; HEXYLRESORCINOL; ASCORBYL GLUCOSIDE; LACTIC ACID; PHENOXYETHANOL; PROPYLENE GLYCOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ALCOHOL; AMMONIA; ISOPROPYL ALCOHOL; WATER; ETHYLHEXYLGLYCERIN; SALICYLIC ACID
Active strength
17; 2.5; 1; .25; 5; .225; .5; .34875; 6.3; 2.75; .75; 7.333; .025; 1 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL
Pharmacologic classes
Acidifying Activity [MoA]
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
AnubisMed

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOLIC ACID17 g/50mL
KOJIC ACID2.5 g/50mL
HEXYLRESORCINOL1 g/50mL
ASCORBYL GLUCOSIDE.25 g/50mL
LACTIC ACID5 g/50mL
PHENOXYETHANOL.225 g/50mL
PROPYLENE GLYCOL.5 g/50mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.34875 g/50mL
ALCOHOL6.3 mL/50mL
AMMONIA2.75 g/50mL
ISOPROPYL ALCOHOL.75 g/50mL
WATER7.333 mL/50mL
ETHYLHEXYLGLYCERIN.025 g/50mL
SALICYLIC ACID1 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0WT12SX38SInternal UNII lookup
6K23F1TT52Internal UNII lookup
R9QTB5E82NInternal UNII lookup
2V52R0NHXWInternal UNII lookup
33X04XA5ATInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
6DC9Q167V3Internal UNII lookup
T4V6TWG28DInternal UNII lookup
3K9958V90MInternal UNII lookup
5138Q19F1XInternal UNII lookup
ND2M416302Internal UNII lookup
059QF0KO0RInternal UNII lookup
147D247K3PInternal UNII lookup
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eca95dde-cb57-2ab6-e053-2995a90af84fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-401-50AnubisMed50 mL in 1 BOTTLELIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-401ANUBISMED (GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID) LIQUID [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_eca95dde-cb57-2ab6-e053-2995a90af84f.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 13 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oil Free Acne WashSALICYLIC ACID 2%CVS Pharmacy, Inc.7a8225ab-b60a-4978-bdfe-db0b00307ef12026-02-03WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDECVS Pharmacy, Inc.d9fbaeba-cebf-4d02-aa7d-3ee1d2fdc50c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M006
Even and Clear Exfoliating WashSALICYLIC ACIDAmbi Enterprises, LLC499d7616-4677-f6a7-e063-6294a90aeaa22026-01-30WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRite Aid Corporationfb90b880-07e5-4bda-b907-228a669505552026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDERite Aid Corporationa51b7668-1ba1-42cb-b804-4fdf766106952026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentSALICYLIC ACIDNatureplex, LLC31b50718-cc60-460d-aad7-b9620970d4112026-01-29WarningsExact identifier
application number: M006
Peace Out Acne CleanserSALICYLIC ACIDPeace Out LLC0a8897b0-cb8f-ba50-e063-6394a90a7f342026-01-29WarningsExact identifier
application number: M006
Peace Out Acne MoisturizerSALICYLIC ACIDPeace Out LLC.18bb4314-0b18-b3bc-e063-6294a90a18542026-01-29WarningsExact identifier
application number: M006
ZITFREE ACNE TREATMENTBENZOYL PEROXIDENatureplex, LLC70c2e3fb-e643-467b-80fd-c40e3c3e95132026-01-29WarningsExact identifier
application number: M006
ProBliva Antibacterial and Acne Body WashANTIBACTERIAL AND ACNE BODY WASHCAVTECH HOLDING LLC496f7a1e-05b6-d434-e063-6394a90afe542026-01-28WarningsExact identifier
application number: M006
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M006
Viaderma Calm Anti-ItchHYDROCORTISONEVIADERMA DISTRIBUTION INCea281bde-a7a2-47b6-895a-5dc2924972de2026-01-27WarningsExact identifier
application number: M006
Viaderma Clear Acne TreatmentSALICYLIC ACIDVIADERMA DISTRIBUTION INCace405bd-6fe6-4db1-ba1f-9b9861abe6632026-01-27WarningsExact identifier
application number: M006
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
application number: M006
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment GelBENZOYL PEROXIDEAkron Pharma Inc.b7d335d1-3022-4b28-913c-477152a7dad22026-01-23WarningsExact identifier
application number: M006
Skinkure Acne Eraser Spot TreatmentSALICYLIC ACIDSKINKURE, LLC0fc85727-4321-7750-e063-6294a90ad3fe2026-01-23WarningsExact identifier
application number: M006
EmuaidSALICYLIC ACIDSpeer Laboratories, LLCa1486276-30f7-4245-815b-d57edf411cda2026-01-23WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne CleanserSALICYLIC ACIDKenvue Brands LLC3e985a61-2aa7-963b-e063-6294a90a7c122026-01-22WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDSKIN PS Brands9629fdcb-f3b5-9685-e053-2a95a90a02302026-01-22WarningsExact identifier
application number: M006
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-401-508302104015050 mL in 1 BOTTLE (83021-401-50) 50 ml2022-11-042027-07-01NoNoCurrent