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 23 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Complexion TonerSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a517dfe5-e4a0-5f2d-e053-2a95a90a2ec12025-10-21WarningsExact identifier
application number: M006
Clear Smart Clarifying Cleansing FoamSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a564d38c-d674-29db-e053-2995a90ab3b42025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Pore HydratorSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.dd6e63a6-91d8-41de-9cb7-f88b68c528d02025-10-21WarningsExact identifier
application number: M006
Acne Fighting Putty PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc657fd325-dd3f-4246-8486-fb5405a52c612025-10-21WarningsExact identifier
application number: M006
Acne Fighting Spot GelSALICYLIC ACIDe.l.f. Cosmetics, Inceca08910-58b9-4ce6-8e97-4b97c30784f52025-10-21WarningsExact identifier
application number: M006
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
application number: M006
Oil-Free Foaming Acne WashSALICYLIC ACIDRejoice Internationalcfc2efe1-3eb4-4262-ba68-d1201770297c2025-10-20WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Lab Inc.41931e38-0e3c-e322-e063-6394a90af4012025-10-20WarningsExact identifier
application number: M006
Acne WashSALICYLIC ACIDTarget Corporation1c81d366-3bf9-c33e-e063-6294a90a3ca22025-10-18WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.41672e2e-2b70-e879-e063-6294a90a81b02025-10-17WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMPERENNEBELL Co., Ltd.0897ccca-fa18-873f-e063-6394a90a59ab2025-10-16WarningsExact identifier
application number: M006
Acne Calming Water CreamSALICYLIC ACIDe.l.f. Cosmetics, Inc.01b70e53-9e24-4950-bbe9-c58905b6e68d2025-10-15WarningsExact identifier
application number: M006
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology9e057f84-0b46-4ffc-a3bb-5bafc8f6baa52025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology1c2d71c5-2560-462f-adec-14bc38550ba42025-10-15WarningsExact identifier
application number: M006
Purifying Clay MaskSALICYLIC ACIDCosmetic Enterprises Ltdd17e3ff5-f7a4-3e14-e053-2995a90a22b22025-10-14WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact 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