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 39 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rush Salicylc Acid Complexion PadsSALICYLIC ACIDG.S. COSMECEUTICAL USA, INC.e9c3c3aa-e0e0-45aa-b97c-dc211e2f62b12024-11-26WarningsExact identifier
application number: M006
EVEN BETTER CLINICAL ACNE SOLUTIONSSALICYLIC ACIDCLINIQUE LABORATORIES LLC02e22431-ae2f-1f42-e063-6394a90aa3af2024-11-25WarningsExact identifier
application number: M006
Oxy Hydrating Anti-Blemish Body WashOXY HYDRATING ANTI-BLEMISH BODY WASHThe Mentholatum Company21b64a3f-2c90-1c1a-e063-6294a90a0ea02024-11-23WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLCf1d1053e-d863-4f02-9339-843d3d3e630e2024-11-20WarningsExact identifier
application number: M006
Equate Acne Wash Acne medicationBENZOYL PEROXIDEWal-Mart Stores, Inc.3c108488-dfaf-447c-ba26-15fd7cf677612024-11-18WarningsExact identifier
application number: M006
ACNE solutions CLARIFYINGSALICYLIC ACIDCLINIQUE LABORATORIES LLCdc1b2e2e-0e13-4029-bdac-44adb70492fd2024-11-18WarningsExact identifier
application number: M006
Meijer Maximum Strength Foaming Acne Face Wash Acne MedicationBENZOYL PEROXIDEMeijer Distribution, Inc4cfbaa79-ee6c-4946-8f8c-cda71b7a80fd2024-11-15WarningsExact identifier
application number: M006
amazon basics acne blackhead clearing scrub Acne TreatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC8e129137-85c6-423d-936e-4266988506a22024-11-15WarningsExact identifier
application number: M006
AGE INTERVENTION DUALITY MDBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.6d885fe2-8a2d-44d4-84d9-932c48260f792024-11-15WarningsExact identifier
application number: M006
AGE INTERVENTION DUALITYBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.33fb5893-ea63-49a3-bb02-6b98c747c4fe2024-11-15WarningsExact identifier
application number: M006
Amazon Basics Acne Wash Acne treatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC2e41ca5f-127a-4387-a64a-c5a4ab36192a2024-11-15WarningsExact identifier
application number: M006
Meijer Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEMeijer Distribution, Inccbf0587a-29c4-47ce-bd09-2bccaddba3b72024-11-15WarningsExact identifier
application number: M006
e.l.f Plz Clarify Facial OilE.L.F PLZ CLARIFY FACIAL OILZhejiang Ayan Biotech Co., Ltd.25a8a0fe-d09b-3e20-e063-6394a90a51f02024-11-14WarningsExact identifier
application number: M006
amazon basics acne foaming cleanser Acne TreatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLCbdfbaeab-137a-49d5-bdc3-06349b8a05642024-11-14WarningsExact identifier
application number: M006
amazon basics advanced blemish spot treatment Acne medicationSALICYLIC ACIDAMAZON.COM SERVICES LLC67c1ef50-ecae-46a5-924e-1cff194810502024-11-14WarningsExact identifier
application number: M006
Neutrogena SkinClearing Mineral Powder Chestnut 135SALICYLIC ACIDKenvue Brands LLC0d1556d3-d689-c4c1-e063-6394a90adab02024-11-13WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLC581ea73f-439a-4290-a8c0-98a25b4496dc2024-11-12WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC2dde181f-d24f-4239-bec5-ded7fdbc98c42024-11-12WarningsExact identifier
application number: M006
Neutrogena deep clean purifying cooling gel scrubSALICYLIC ACIDKenvue Brands LLCda2ce634-36c4-b5b7-e053-2a95a90abefb2024-11-12WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Mattifying Acne MoisturizerSALICYLIC ACIDGalderma Laboratories, L.P.72977030-d9b6-435f-b321-edcbbb7315872024-11-12WarningsExact 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