FDA.reportPublic FDA data

AnubisMed

Product NDC
83021-402
11-digit product format
830210402
Labeler code
83021
Product ID
83021-402_049fca13-6921-d895-e063-6294a90a42da
Type
HUMAN OTC DRUG
Nonproprietary name
Azelaic Acid, Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-26
Marketing end
2027-09-08
Substance
AZELAIC ACID; POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; ISOPROPYL ALCOHOL; WATER; SALICYLIC ACID; ALCOHOL
Active strength
7; 4.9965; 10; 2.7; 1.62; 1; 22.68 g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; mL/50mL
Pharmacologic classes
Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
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
AZELAIC ACID7 g/50mL
POLYETHYLENE GLYCOL 4004.9965 g/50mL
PROPYLENE GLYCOL10 g/50mL
ISOPROPYL ALCOHOL2.7 g/50mL
WATER1.62 mL/50mL
SALICYLIC ACID1 g/50mL
ALCOHOL22.68 mL/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2VW3D43YTInternal UNII lookup
B697894SGQInternal UNII lookup
6DC9Q167V3Internal UNII lookup
ND2M416302Internal UNII lookup
059QF0KO0RInternal UNII lookup
O414PZ4LPZInternal UNII lookup
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebf3153d-30f5-54e4-e053-2995a90a74b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-402-50AnubisMed50 mL in 1 BOTTLE, GLASSLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-402ANUBISMED (AZELAIC ACID, SALICYLIC ACID) LIQUID [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_ebf3153d-30f5-54e4-e053-2995a90a74b1.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 11 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing TreatmentSALICYLIC ACIDSICOS ET CIE6e366dc4-288a-47b1-ab72-8ed3aa6aea222026-03-02WarningsExact identifier
application number: M006
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing TreatmentSALICYLIC ACIDLOreal USA Products Incc5ce4ec6-176f-4bb0-96f0-6817e53c14682026-03-02WarningsExact identifier
application number: M006
FOLUPIA MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4bca1a8b-2df4-47b1-e063-6394a90a33ff2026-02-27WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDWalmart Inc.56e29d46-a29d-4192-9fdf-58dbcb843d442026-02-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalmart Inc.950edb4e-fbba-41e3-9ec5-973806e555e72026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDWalmart Inc.c31a5629-66c3-47a7-96ea-9987b2be82af2026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDWalmart Inc.2df52d35-dbb6-1d35-e063-6394a90ae1102026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Quick ActionSALICYLIC ACIDWalmart Inc.00025ea5-d15f-49d2-a52a-6c1bd8c6a0332026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Walmart Inc.31e49de0-0806-d18b-e063-6294a90ae47d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
ACNE SOLUTIONS SPOT HEALING ACNE MEDICATIONSALICYLIC ACIDCLINIQUE LABORATORIES LLCc09ee4f6-b8f9-4d20-982a-fb490830bd342026-02-26WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEThe Kroger Co.a6526d73-4094-45b7-97f0-561dd10d61e22026-02-26Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Meijer, Inc.29a62723-a58d-4912-bdab-b2fa1fac27b42026-02-24Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDMeijer, Inc.3aeb4f0b-a8f7-4ed7-b320-45e5ba0c81752026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEMeijer, Inc.932ee049-ab3d-4839-a655-772e5594f6e12026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
PHARMA CLEAR SPOT TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC24736409-b500-4aae-857e-1f4fb1760a152026-02-19WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDUnited Natural Foods, Inc. dba UNFI1a4df18d-8128-4846-80bc-262ba1a2aeca2026-02-17Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%United Natural Foods, Inc. dba UNFIc489c818-d69a-4011-9c37-60c8c5b9522a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDUnited Natural Foods, Inc. dba UNFI677c19eb-780b-479b-ab1d-df249e0af6ea2026-02-16Warnings, Adverse reactionsExact identifier
application number: M006
PoreFectSALICYLIC ACIDOur-Science Inc.4afe4115-cdf0-6dd3-e063-6394a90a24532026-02-16WarningsExact identifier
application number: M006
iShancare Folliculitis CreamFOLLICULITIS CREAMShenzhen Ishan Technology Co., Ltd0c85c8e9-f50f-1b72-e063-6394a90a88c42026-02-13WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-402-508302104025050 mL in 1 BOTTLE, GLASS (83021-402-50) 50 ml2022-10-262027-09-08NoNoCurrent