FDA.reportPublic FDA data

Spot Stopper Acne Spot Treatment

Product NDC
69366-412
11-digit product format
693660412
Labeler code
69366
Product ID
69366-412_0ce46087-f196-a862-e063-6294a90aa421
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
The Honest Company, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
SALICYLIC ACID
Active strength
2 g/100mL
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
Spot Stopper Acne Spot Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

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
346298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc7afebd-e212-b9ff-e053-2a95a90a15a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-412-322023-12-19C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment
69366-412-322023-07-28C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-412-32Spot Stopper Acne Spot Treatment1 in 1 CARTONGEL12
69366-412-32Spot Stopper Acne Spot Treatment15 mL in 1 TUBEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-412SPOT STOPPER ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [THE HONEST COMPANY, INC]2Current NDC, Legacy NDC, 2 package rows20231220_dc7afebd-e212-b9ff-e053-2a95a90a15a5.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 41 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
application number: M006
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
application number: M006
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
application number: M006
Aveeno CLEAR COMPLEXION foaming cleanserSALICYLIC ACIDKenvue Brands LLC32425c63-7ed9-401b-a271-988b52b4f1052024-11-05WarningsExact identifier
application number: M006
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
application number: M006
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
application number: M006
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medicationSALICYLIC ACIDMeijer Distribution, Inc3232b833-225f-429f-910c-d11874f3f1d52024-11-05WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC817a9746-df57-4b11-b580-f57fe9940a682024-11-01WarningsExact identifier
application number: M006
SkinMedica Acne Clarifying TreatmentSALICYLIC ACIDAllergan, Inc.664d4733-e72d-410a-8ed0-a159d9dfa2362024-11-01WarningsExact identifier
application number: M006
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
application number: M006
Walgreens Acne Foaming Wash Acne MedicationBENZOYL PEROXIDEWalgreen Companyf34affe9-d470-48a5-b0d1-d62b9c44b3f22024-10-31WarningsExact identifier
application number: M006
Clearing Skin WashSALICYLIC ACIDDermalogica, LLC.5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf2024-10-30WarningsExact identifier
application number: M006
Walgreens Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEWalgreen Company5b6fab38-4a9e-4c5c-967e-e3a0ff03b6062024-10-30WarningsExact identifier
application number: M006
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9702add4-ea36-4c6b-9402-87b44f989a802024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd7441981a-654d-4f18-be21-66c863ee6d6f2024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f2024-10-23WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSNdc7afebd-e212-b9ff-e053-2a95a90a15a52
346298salicylic acid 0.02 MG/MG Topical GelSCDdc7afebd-e212-b9ff-e053-2a95a90a15a52
346298salicylic acid 2 % Topical GelSYdc7afebd-e212-b9ff-e053-2a95a90a15a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69366-412-32693660412321 TUBE in 1 CARTON (69366-412-32) / 15 mL in 1 TUBE1 tube2022-05-010000-00-00NoNoCurrent