FDA.reportPublic FDA data

Azelaq

Product NDC
87110-003
11-digit product format
871100003
Labeler code
87110
Product ID
87110-003_43084456-e453-07d9-e063-6294a90a36c8
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
METHODIQ INC.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-18
Substance
SALICYLIC ACID
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Azelaq
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252296Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43084456-e452-07d9-e063-6294a90a36c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87110-003-01Azelaq15 mL in 1 BOTTLE, PUMPGEL151
87110-003-01Azelaq1 in 1 CARTONGEL11

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252296salicylic acid 0.5 % Topical GelPSN43084456-e452-07d9-e063-6294a90a36c81
252296salicylic acid 0.005 MG/MG Topical GelSCD43084456-e452-07d9-e063-6294a90a36c81
252296salicylic acid 0.5 % Topical GelSY43084456-e452-07d9-e063-6294a90a36c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87110-003-01871100003011 BOTTLE, PUMP in 1 CARTON (87110-003-01) / 15 mL in 1 BOTTLE, PUMP2025-11-18NoNoCurrent