Azelaq

Product NDC
87110-003
Requested package NDC
87110-003-01
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 50 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Med 5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b11-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Face and Body WashBENZOYL PEROXIDEFace Reality Skin Care, LLC454983d2-4aec-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 2.5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b0f-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Nighttime ControlBENZOYL PEROXIDECircadia by Dr Pugliese, Inc.fb4cc832-4cfd-4e29-a78e-ab848681a2242023-12-15WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5056320e-e472-44ed-9afd-759ba55f0fd72023-12-13WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION418d480c-4131-4262-bb56-d5b10bbf7dcb2023-12-13WarningsExact identifier
application number: M006
Acne Advanced Clarifying MasqueSALICYLIC ACIDEminence Organic Skin Care Ltd.7916a299-fc90-4eb7-882f-4caa39e2c7aa2023-12-12WarningsExact identifier
application number: M006
Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over TreatmentSALICYLIC ACIDFlageoli Limitedeb57517c-cf9e-4272-9c00-380385f916e02023-12-12WarningsExact identifier
application number: M006
111MedCo 6% Sulfur Skin Cleansing BarSULFUR111MedCo LLC7a2d647f-f10f-4637-b28b-319fed93677b2023-12-12WarningsExact identifier
application number: M006
111MedCo 2% Salicylic Acid Cleansing BarSALICYLIC ACID111MedCo LLC6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a2023-12-12WarningsExact identifier
application number: M006
111 Medco Benzoyl PeroxideBENZOYL PEROXIDE111 Medco8590214e-e5a7-8934-e053-2a91aa0a248b2023-12-12WarningsExact identifier
application number: M006
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
application number: M006
Differin Daily Deep Cleanser with BPOBENZOYL PEROXIDEGalderma Laboratories, L.P.192b231b-51f1-457c-9a82-ef75671c0d342023-12-11WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION04df2f5d-77f0-4553-9d8c-3f10628736ae2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact 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