FDA.reportPublic FDA data

salicylic acid

Product NDC
83324-182
11-digit product format
833240182
Labeler code
83324
Product ID
83324-182_57358f8f-55fb-c3ac-e063-6294a90a54f9
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-22
Substance
SALICYLIC ACID
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
salicylic acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dc96074-50a1-baa8-e063-6294a90a5aabAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

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 21 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne CleanserSALICYLIC ACIDCurology44730f63-1f22-27a5-e063-6294a90a63c22025-11-25WarningsExact identifier
application number: M006
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
application number: M006
Shaant Pore Purifying Face ScrubSALICYLIC ACIDCodex Labs Corporationd806e749-ea2c-4db4-af65-a1f8afce1b0e2025-11-21WarningsExact identifier
application number: M006
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
application number: M006
Shaant Hydrating Body ScrubSALICYLIC ACIDCodex Labs Corporation64a176a1-7dc4-44f8-8b3d-4349460a17b02025-11-21WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.4401fff2-725f-8ff0-e063-6294a90ae9ba2025-11-20WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.440a3a73-7136-f8b2-e063-6394a90a744d2025-11-20WarningsExact identifier
application number: M006
Acne Defense Spot Treatment Merle NormanSALICYLIC ACIDMerle Norman Cosmetics, Incc6296d3a-fabe-4a8f-91e8-cac2ae6ff9262025-11-18WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming and Soothing Clay MaskSALICYLIC ACIDTHG Beauty USA LLC23a3d093-e89b-ddaf-e063-6394a90aaa6a2025-11-14WarningsExact identifier
application number: M006
Daily MedsSALICYLIC ACIDBioelements, Inc.3ffb6cd0-c529-4420-8da8-de52838d8a642025-11-14WarningsExact identifier
application number: M006
Naturium Encapsulated Salicylic Acid Moisturizer 0.75%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a4a0de1-6feb-bf9a-e063-6394a90a32d92025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Body 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a5b80fb-caec-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Serum 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a28640e-37f8-9a74-e063-6294a90a15b72025-11-14WarningsExact identifier
application number: M006
Naturium Sulfur Spot Treatment 8%SULFURe.l.f. Cosmetics, Inc0a4a9aed-5eeb-f648-e063-6394a90a1d762025-11-14WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACID ACNE TREATMENTCosMedical Technologies23bd8842-5237-4131-e054-00144ff8d46c2025-11-13WarningsExact identifier
application number: M006
Overnight Spot TreatmentACNE TREATMENTCosMedical Technologies23bde802-d84a-1ecc-e054-00144ff88e882025-11-13WarningsExact identifier
application number: M006
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634560{1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSNa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackSYa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1086991APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa92bcefb-ba29-4b3f-a60b-b4476ca8cf042
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa92bcefb-ba29-4b3f-a60b-b4476ca8cf042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-182-4283324018242124 mL in 1 TUBE (83324-182-42) 124 ml2026-07-22NoNoCurrent