FDA.reportPublic FDA data

Salicylic Acid

Product NDC
80861-117
11-digit product format
808610117
Labeler code
80861
Product ID
80861-117_57f48c82-691d-3e4a-e063-6294a90a9064
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Acne Free, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-05
Substance
SALICYLIC ACID
Active strength
.02 g/g
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 ACID.02 g/g

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
562600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1097fc73-fa47-0f14-e063-6294a90aa499Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-117-01Salicylic Acid1 g in 1 TUBECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-117SALICYLIC ACID CREAM [ACNE FREE, LLC]2Current NDC, 1 package rows20240620_1097fc73-fa47-0f14-e063-6294a90aa499.zip

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 4 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1097fc73-fa47-0f14-e063-6294a90aa4993
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1097fc73-fa47-0f14-e063-6294a90aa4993
562600salicylic acid 2 % Facial Cleanser TonerSY1097fc73-fa47-0f14-e063-6294a90aa4993
562600salicylic acid 2 % Facial ScrubSY1097fc73-fa47-0f14-e063-6294a90aa4993
562600salicylic acid 2 % Medicated Liquid SoapSY1097fc73-fa47-0f14-e063-6294a90aa4993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80861-117-01808610117011 g in 1 TUBE (80861-117-01) 1 g2024-02-05NoNoCurrent