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
ALCOHOL; AMMONIA; ASCORBYL GLUCOSIDE; ETHYLHEXYLGLYCERIN; GLYCOLIC ACID; HEXYLRESORCINOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; KOJIC ACID; LACTIC ACID; PHENOXYETHANOL; PROPYLENE GLYCOL; SALICYLIC ACID; WATER
Active strength
6.3; 2.75; .25; .025; 17; 1; .34875; .75; 2.5; 5; .225; .5; 1; 7.333 mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL
Pharmacologic classes
Acidifying Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AnubisMed

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOLIC ACID6.3 mL/50mL
KOJIC ACID2.75 g/50mL
HEXYLRESORCINOL.25 g/50mL
ASCORBYL GLUCOSIDE.025 g/50mL
LACTIC ACID17 g/50mL
PHENOXYETHANOL1 g/50mL
PROPYLENE GLYCOL.34875 g/50mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.75 g/50mL
ALCOHOL2.5 g/50mL
AMMONIA5 g/50mL
ISOPROPYL ALCOHOL.225 g/50mL
WATER.5 g/50mL
ETHYLHEXYLGLYCERIN1 g/50mL
SALICYLIC ACID7.333 mL/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 1 of 55 · 1,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Terminator 10BENZOYL PEROXIDEAcneFree, LLCc06778b6-0ed6-7d82-e053-2a95a90a2ef82026-07-31WarningsExact identifier
application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl PeroxideBENZOYL PEROXIDEAcneFree LLCc939847a-72cc-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Benzoyl Peroxide Deep Cleansing Foaming WashBENZOYL PEROXIDEAcneFree, LLCfe2d0e24-8c68-b2ea-e053-6294a90ad72c2026-07-31WarningsExact identifier
application number: M006
Salicylic AcidSALICYLIC ACIDAcne Free, LLC1097fc73-fa47-0f14-e063-6294a90aa4992026-07-31WarningsExact identifier
application number: M006
Even and Clear CleanserSALICYLIC ACIDAmbi Enterprises LLCbff537cf-aa79-5250-e053-2995a90a388a2026-07-31WarningsExact identifier
application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne CleanserBENZOYL PEROXIDEAcneFree, LLCc7a675fa-b6c0-6237-e053-2a95a90a04062026-07-31WarningsExact identifier
application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939681e-ea93-31ce-e053-2a95a90a8c702026-07-31WarningsExact identifier
application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing SystemSALICYLIC ACID, BENZOYL PEROXIDEAcneFree LLCc9397a25-8fed-48d0-e053-2a95a90ab4952026-07-31WarningsExact identifier
application number: M006
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
application number: M006
24 Hour Sensitive Skin Acne Clearing SystemSALICYLIC ACIDAcne Free LLC39ea674d-ff6e-a8c6-e063-6394a90a06562026-07-31WarningsExact identifier
application number: M006
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact 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