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 43 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET UP AND UP ACNE MEDICATIONBENZOYL PEROXIDETARGET CORPORATIONbadbe092-eaff-1163-e053-2a95a90abb6e2024-10-14WarningsExact identifier
application number: M006
Target Up and Up Acne Spot TreatmentBENZOYL PEROXIDETARGET CORPORATIONf12eface-bf9c-33fd-e053-2a95a90a7b352024-10-14WarningsExact identifier
application number: M006
Target Up and Up 3 Step Acne SystemBENZOYL PEROXIDETARGET CORPORATIONf784bd99-0b8a-2521-e053-6294a90a25192024-10-14WarningsExact identifier
application number: M006
Up and Up Blemish Controlling Apricot ScrubSALICYLIC ACIDTARGET CORPORATION92d44bd6-bea8-6134-e053-2995a90ad1202024-10-14WarningsExact identifier
application number: M006
Up and Up Deep Clean TonerSALICYLIC ACIDTARGET CORPORATION945b0588-6864-27bc-e053-2995a90a73e32024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE BLEMISH AND BLACKHEAD CONTROLSALICYLIC ACIDSAFEWAY, INC.a573c428-870d-0bf7-e053-2995a90a595a2024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE ACNE MEDICATIONBENZOYL PEROXIDESAFEWAY, INC.a62af431-b033-3603-e053-2995a90a961e2024-10-14WarningsExact identifier
application number: M006
Signature Care Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDSafeway, Inc.baee746b-cb5d-3621-e053-2a95a90a302f2024-10-14WarningsExact identifier
application number: M006
Walgreens Acne Spot TreatmentBENZOYL PEROXIDEWALGREEN COMPANYf12d432e-3115-47ec-e053-2a95a90a69d32024-10-11WarningsExact identifier
application number: M006
Walgreens 3 Step Acne SystemBENZOYL PEROXIDEWALGREEN COMPANYf7933ecd-4fc7-8526-e053-6394a90a15c52024-10-11WarningsExact identifier
application number: M006
ClearSynergySALICYLIC ACIDSRL Enterprises, LLCb0ad3d4c-7afa-4503-b5d6-c88bf898155e2024-10-08WarningsExact identifier
application number: M006
Asepxia Acne TreatmentSALICYLIC ACIDGenomma Lab USA910d4320-bf89-436a-a8d4-54d001281dee2024-10-08WarningsExact identifier
application number: M006
Asepxia AcneSALICYLIC ACIDGenomma Lab USA9e8de726-480c-44c7-82c8-ce66412d881e2024-10-07WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepackd3f16759-1ddf-4cfc-8b93-f60e680ba2f82024-10-03WarningsExact identifier
application number: M006
Atrix Clarifying TonerSALICYLIC ACIDPureTek Corporation191a2f96-eb97-4b45-b6a8-0d5835e7e7572024-10-02WarningsExact identifier
application number: M006
ZO Skin Health Retinol Plus Acne ComplexSALICYLIC ACIDZO Skin Health, Inc.1d65e4d2-0856-9135-e063-6294a90a5c662024-10-01WarningsExact identifier
application number: M006
Atrix Acne TreatmentSALICYLIC ACIDPureTek Corporationba106b20-32aa-df90-e053-2995a90adaef2024-10-01WarningsExact identifier
application number: M006
Atrix Antibacterial WashSALICYLIC ACIDPURETEK CORPORATIONbd5b6f29-5b97-0853-e053-2a95a90aed592024-10-01WarningsExact identifier
application number: M006
Target Up and Up Salicylic Acid Acne WashSALICYLIC ACIDTARGET CORPORATION235aa04e-746f-d66a-e063-6394a90a11442024-09-30WarningsExact identifier
application number: M006
Target Up and Up Benzoyl Peroxide Acne WashBENZOYL PEROXIDETARGET CORPORATION235b9df0-41dd-5476-e063-6394a90ae6682024-09-30WarningsExact 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