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 6 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlowBiotic Probiotic Acne CleanserSALICYLIC ACIDGlowbiotics546334bf-cf47-a1e5-e063-6394a90a590c2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5464d48b-495c-e45f-e063-6394a90aedfc2026-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION54650326-1582-26b7-e063-6394a90a575c2026-06-16WarningsExact identifier
application number: M006
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare316702b8-4f9d-0a42-e063-6394a90ad8e12026-06-11WarningsExact identifier
application number: M006
Proven Acne CleanserSALICYLIC ACIDProven Skincare31a29bdd-a218-247a-e063-6294a90a8cee2026-06-11WarningsExact identifier
application number: M006
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDTwincraft Inc.4911ef14-b465-3398-e063-6394a90a9c9a2026-06-09WarningsExact identifier
application number: M006
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
application number: M006
Acne Control SerumBENZOYL PEROXIDEPrivate Label Skin Cared4a4b89f-c9cf-4188-9c61-e8ef22b7638c2026-06-03WarningsExact identifier
application number: M006
BellamiLuxx Body acne cleanserBENZOYL PEROXIDE 4%BellamiLuxx LLC532baae0-7e6f-1764-e063-6394a90a11ce2026-06-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC532c48d7-6d7b-ba96-e063-6394a90a9c302026-06-01WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDLOreal USA Products Inc727fa830-1f71-40ae-8153-7a29dbcb5e292026-06-01WarningsExact identifier
application number: M006
Hero Pore Release Blackhead ClearingSALICYLIC ACIDChurch & Dwight Co., Inc.436cf03c-3f74-4a02-bb0a-1d24f5c4fc292026-06-01WarningsExact identifier
application number: M006
Principal Secret Blemish Buster ClearSALICYLIC ACIDGuthy-Renker LLC75387738-eca2-4184-833b-95005eb276662026-05-29WarningsExact identifier
application number: M006
KUGIG ACNE TREATMENT SPRAYERSALICYLIC ACIDGuangdong Jiaoyu Biotechnology Co., Ltd.52b1e9cb-c083-a6eb-e063-6294a90ab6d12026-05-26WarningsExact identifier
application number: M006
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.201eeecd-e759-42b8-b5c2-b19465d983322026-05-25WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.a5431ecd-0afc-4525-9157-ee05ff752df52026-05-25WarningsExact identifier
application number: M006
XEXLVOV MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd529bf32f-b40b-9602-e063-6294a90a1c2a2026-05-24WarningsExact 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