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 17 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENTSALICYLIC ACIDSHISEIDO AMERICAS CORPORATION3b584705-21a8-4e37-96cc-f9c8058db5c42026-01-05WarningsExact identifier
application number: M006
I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSERSALICYLIC ACIDMemebox Corporation297bbe36-23be-0995-e063-6294a90a98df2026-01-01WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f422026-01-01WarningsExact identifier
application number: M006
Acne Treatment GelSALICYLIC ACIDS+688783fd-574e-40dd-a4cb-c59afdebcddc2025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Acne All-Over Clearing Serum Cleansing SerumSALICYLIC ACIDMelaleuca, Inc.19266ab3-54cd-225d-e063-6294a90aa5122025-12-31WarningsExact identifier
application number: M006
Clarity Clear Skin Solutions Acne Spot TreatmentBENZOYL PEROXIDEMelaleuca, Inc.193667e8-3a4d-9270-e063-6294a90a1c262025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatmentSALICYLIC ACIDMelaleuca, Inc.19370e9a-4907-2ddc-e063-6294a90a97112025-12-31WarningsExact identifier
application number: M006
CLEAR MED 10%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC7acd1404-2af7-4ec4-b1e9-a905c9f823b82025-12-31WarningsExact identifier
application number: M006
CLEAR MED 5%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC03799b2c-cab1-4672-9004-29e4873d022f2025-12-31WarningsExact identifier
application number: M006
SALICYLIC WASHSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC3c6fee91-6f02-40b6-b71f-495b4f235d172025-12-31WarningsExact identifier
application number: M006
SULFUR CALMING MASKSULFURCONTROL CORRECTIVE SKINCARE INC446bd2ea-da88-422a-b086-e61b2d5b62692025-12-31WarningsExact identifier
application number: M006
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
application number: M006
EXFO TONIC ACNE TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC782867ee-8e38-42fc-bd31-c16e618b01d22025-12-31WarningsExact identifier
application number: M006
THYLOXSULFURBradford Soap Works, Inc.5f52b769-9893-4391-b98f-3765e7b494852025-12-31WarningsExact identifier
application number: M006
AVEDA OUTER PEACE ACNE RELIEF PADSSALICYLIC ACIDAveda Corporationc37052cc-6705-48ff-adf1-0dec7d7360072025-12-31WarningsExact identifier
application number: M006
Acne Care Charcoal CleanserACNE CARE CHARCOAL CLEANSERWhole Foods Market891c09a1-116b-3afd-e053-2995a90a856c2025-12-30WarningsExact identifier
application number: M006
Acne Care MoisturizerACNE CARE MOISTURIZERWhole Foods Market8957fab8-ec9c-2494-e053-2995a90a6c292025-12-30WarningsExact identifier
application number: M006
Body Acne TreatmentBODY SPRAYSkin PS Brands099ddba5-8e34-1e11-e063-6294a90af4c02025-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHSkin PS Brandsfb230cde-b225-6df6-e053-6294a90aa6532025-12-30WarningsExact identifier
application number: M006
BP Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsfeb0ed89-878b-2497-e053-6394a90ad1c12025-12-30WarningsExact 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