FDA.reportPublic FDA data

Salicylic Acid

Product NDC
36800-875
11-digit product format
368000875
Labeler code
36800
Product ID
36800-875_4ab9e538-f943-9d4c-e063-6394a90a30ce
Type
HUMAN OTC DRUG
Nonproprietary name
Astringent
Dosage form
LIQUID
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-01
Substance
SALICYLIC ACID
Active strength
5 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 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
199308Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d15560f-d8d1-4dfe-8eca-b16bb529ad87Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-875-34Salicylic Acid237 mL in 1 BOTTLE, PLASTICLIQUID23713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-875SALICYLIC ACID (ASTRINGENT) LIQUID [TOPCO ASSOCIATES LLC]11Current NDC, Legacy NDC, 1 package rows20240802_7d15560f-d8d1-4dfe-8eca-b16bb529ad87.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 15 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peace Out Acne SerumSALICYLIC ACIDPeace Out LLC.7cd68513-0470-4409-82d0-619c97e69ff42026-01-14WarningsExact identifier
application number: M006
MEDPURA Benzoyl PeroxideBENZOYL PEROXIDEAkron Pharma Inc.1b051efe-054b-42a0-915a-b87885bd3c542026-01-13WarningsExact identifier
application number: M006
END-ZITSULFURABBE Laboratories, Inc.afed5e8e-324c-44c6-abf6-72938376a4b22026-01-13WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCc4775032-9723-4208-8a42-145f2b4da1c82026-01-12WarningsExact identifier
application number: M006
BHA CLEANSER 2%SALICYLIC ACIDSkinfix, Inc.ceccb599-ff9e-fc87-e053-2a95a90a411a2026-01-12WarningsExact identifier
application number: M006
ACNE SPOT TREATMENT 2% BHASALICYLIC ACIDSkinfix, Inc.ceccea68-07d8-0903-e053-2995a90ab2b72026-01-12WarningsExact identifier
application number: M006
Sulfo loSULFUR 3% SOAP BARCrown Laboratories89577417-76a0-cb04-e053-2995a90a57332026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories1660f219-e789-91f1-e063-6294a90a76642026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratoriesff09cbab-304b-4da9-e053-6394a90ae6002026-01-12WarningsExact identifier
application number: M006
PanOxyl Clarifying ExfoliantSALICYLIC ACIDCrown Laboratories, Inc.faa6576c-2af2-d86b-e053-6294a90ada2d2026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories7b301b94-3cc8-b05b-e053-2991aa0aa5612026-01-12WarningsExact identifier
application number: M006
PanOxyl Acne Gel WashSALICYLIC ACIDCrown Laboratories, Inc.39712bb8-3d4e-29b3-e063-6394a90a95b82026-01-12WarningsExact identifier
application number: M006
Proactiv Clean Mineral Acne CleanserSULFURAlchemee, LLC380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b2026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Acne Clearing HydratorSALICYLIC ACIDAlchemee, LLC33ac397c-55af-4a50-b5ce-80f8a88015812026-01-07WarningsExact identifier
application number: M006
Proactiv CLEAR ZONE BODY PADSSALICYLIC ACIDAlchemee, LLCcf9e5536-08f6-4bbd-9e09-2e9a0c768ed92026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Complexion Perfecting HydratorSALICYLIC ACIDAlchemee, LLCc9b91b61-738e-474e-927f-0806264c739e2026-01-07WarningsExact identifier
application number: M006
Proactiv plus Pore Targeting TreatmentBENZOYL PEROXIDEAlchemee, LLC12f2eeab-d258-4eb1-8fe2-784c51c2e4cc2026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Retexturizing TonerSALICYLIC ACIDAlchemee, LLC7c211ff7-920f-407b-ad8d-60d14803b8572026-01-07WarningsExact identifier
application number: M006
Proactiv Clarifying NightSALICYLIC ACIDAlchemee, LLC8b81b4e5-f2fc-45a1-923a-7c326529d68b2026-01-07WarningsExact identifier
application number: M006
Proactiv Emergency Blemish ReliefBENZOYL PEROXIDEAlchemee, LLC72bb45ca-3f68-47be-928e-755cc66419d92026-01-07WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199308salicylic acid 0.5 % Topical SolutionPSN7d15560f-d8d1-4dfe-8eca-b16bb529ad8713
199308salicylic acid 5 MG/ML Topical SolutionSCD7d15560f-d8d1-4dfe-8eca-b16bb529ad8713
199308salicylic acid 0.5 % Topical SolutionSY7d15560f-d8d1-4dfe-8eca-b16bb529ad8713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-875-3436800087534237 mL in 1 BOTTLE, PLASTIC (36800-875-34) 237 ml2009-06-010000-00-00NoNoCurrent