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 52 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
application number: M006
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
application number: M006
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
application number: M006
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
application number: M006
MD-Acne Body Acne TreatmentBENZOYL PEROXIDEMD Algorithms Inc.97981e9b-d56a-42f6-a75f-647b4732021e2023-11-11WarningsExact identifier
application number: M006
ACNE THERAPYBENZOYL PEROXIDEmenScience Androceuticals, LLC4dec259d-200e-44f2-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M006
HUMANE Acne Spot TreatmentBENZOYL PEROXIDEApprendista, LLCceeb398e-c516-45e4-a21c-cbecf6206fcc2023-11-11WarningsExact identifier
application number: M006
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
application number: M006
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
application number: M006
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
application number: M006
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
application number: M006
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
application number: M006
ACNE FORTE Acne Treatment CreamBENZOYL PEROXIDEGSCM Ventures Inc. DBA Revitolc29ed6c1-b8ad-4131-a94c-379f16ab2ee52023-11-10WarningsExact identifier
application number: M006
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
application number: M006
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
application number: M006
Asepxia Neutral Acne BarSALICYLIC ACIDGenomma Lab USAb3995e68-d364-4d96-8148-b456087b42972023-11-06WarningsExact 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