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 45 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006
Replenix Gly-Sal 10-2 cleanserSALICYLIC ACIDTopiderm, Inc.00d1f8af-88de-4a14-80ec-5ee9fd38b1912024-08-02WarningsExact identifier
application number: M006
AL0076001 Alba Botanica Acnedote Deep Pore WashSALICYLIC ACIDThe Hain Celestial Group, Inc.6157c9c6-f252-5b49-e053-2991aa0ad8ed2024-07-31WarningsExact identifier
application number: M006
AL00761 Alba Botanica Acnedote Face and Body ScrubSALICYLIC ACIDThe Hain Celestial Group, Inc.c55efca6-5a5b-134b-e053-2a95a90a82452024-07-31WarningsExact identifier
application number: M006
Gly-Sal 5-2SALICYLIC ACIDTopiderm, Inc.a75e4cee-678f-4e44-9e5e-bafae1c23f9b2024-07-31WarningsExact identifier
application number: M006
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
application number: M006
Face Reality 5% Advanced Acne MedBENZOYL PEROXIDEFace Reality0e52972d-b4d9-43f8-8dbb-2eec0782e0f72024-07-26WarningsExact identifier
application number: M006
Face Reality 10% Advanced Acne MedBENZOYL PEROXIDEFace Realitya214ea15-6346-4729-ba84-fbc842faf92a2024-07-26WarningsExact identifier
application number: M006
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Double Action Acne SerumSALICYLIC ACIDL'Oreal USA Products Incf9daadf9-a9d3-4f2d-af07-5f0b70f7803f2024-07-17WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c7164d75-75e7-494a-9595-028ecbf262762024-07-14WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.286f642f-7359-41b9-9daf-e866a87fbefa2024-07-14WarningsExact 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