FDA.reportPublic FDA data

SkinCeuticals Silymarin CF Acne Treatment

Product NDC
49967-068
11-digit product format
499670068
Labeler code
49967
Product ID
49967-068_2b72a13a-b70e-4947-8705-c64d4d0d47f8
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOLUTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-31
Substance
SALICYLIC ACID
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
SkinCeuticals Silymarin CF Acne Treatment
Listing expiration
2026-12-31

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
aa439d77-7ba5-4699-8e8b-3bba35f5094dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-068-01SkinCeuticals Silymarin CF Acne Treatment30 mL in 1 BOTTLESOLUTION304
49967-068-01SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-02SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-02SkinCeuticals Silymarin CF Acne Treatment55 mL in 1 BOTTLESOLUTION554
49967-068-03SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-03SkinCeuticals Silymarin CF Acne Treatment15 mL in 1 BOTTLESOLUTION154
49967-068-04SkinCeuticals Silymarin CF Acne Treatment10 in 1 CARTONSOLUTION104
49967-068-04SkinCeuticals Silymarin CF Acne Treatment4 mL in 1 VIALSOLUTION44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-068SKINCEUTICALS SILYMARIN CF ACNE TREATMENT (SALICYLIC ACID) SOLUTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 8 package rows20231212_aa439d77-7ba5-4699-8e8b-3bba35f5094d.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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony 10% SulfurSULFURD3 Development, Inc.c78ead80-a8ee-0b52-e053-2a95a90ab8802025-12-01WarningsExact identifier
application number: M006
Dermaharmony 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDOars And Alps LLCefe14f46-c947-aea4-e053-2a95a90aad5f2025-12-01WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199308salicylic acid 0.5 % Topical SolutionPSNaa439d77-7ba5-4699-8e8b-3bba35f5094d4
199308salicylic acid 5 MG/ML Topical SolutionSCDaa439d77-7ba5-4699-8e8b-3bba35f5094d4
199308salicylic acid 0.5 % Topical SolutionSYaa439d77-7ba5-4699-8e8b-3bba35f5094d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-068-01499670068011 BOTTLE in 1 CARTON (49967-068-01) / 30 mL in 1 BOTTLE1 bottle2021-01-010000-00-00NoNoCurrent
49967-068-02499670068021 BOTTLE in 1 CARTON (49967-068-02) / 55 mL in 1 BOTTLE1 bottle2021-01-010000-00-00NoNoCurrent
49967-068-03499670068031 BOTTLE in 1 CARTON (49967-068-03) / 15 mL in 1 BOTTLE1 bottle2021-01-010000-00-00NoNoCurrent
49967-068-044996700680410 VIAL in 1 CARTON (49967-068-04) / 4 mL in 1 VIAL10 vial2021-01-010000-00-00NoNoCurrent