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 32 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006
Dry It Out Acne Spot TreatmentSALICYLIC ACIDPacifica Beauty, LLCf44c0be7-9565-0068-e053-2a95a90a97052025-01-03WarningsExact identifier
application number: M006
Pacifica Bacne WarriorSALICYLIC ACIDPacifica Beauty, LLCf2b77c4f-f181-76cb-e053-2995a90a6cc12025-01-03WarningsExact identifier
application number: M006
Clarifying BacneSALICYLIC ACIDDermalogica, LLC.eb13bf93-2554-4666-bd74-637b2eed7b502025-01-02WarningsExact identifier
application number: M006
CLN ACNE CLEANSERSALICYLIC ACID 0.5% LIQUIDTopMD Skin Care, Inc.1b2f4718-b174-9b50-e063-6394a90ac2f42025-01-02WarningsExact identifier
application number: M006
Biore Witch Hazel Pore Clarifying CleanserSALICYLIC ACIDKao USA Inc.7c107414-457b-1ab0-e053-2991aa0af55a2025-01-01WarningsExact identifier
application number: M006
Biore Blemish Fighting Ice CleanserSALICYLIC ACIDKao USA Inc.e105ed47-d161-4563-a05f-f2e245659aee2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
application number: M006
CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC268bf278-3f18-4410-b552-25baadb9f96c2025-01-01WarningsExact identifier
application number: M006
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a932c8f-3a48-dfcd-e063-6394a90ac20b2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a9315ce-f4da-6a1e-e063-6294a90a8f422024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAY2a92bd47-0d91-00b9-e063-6294a90ae1d62024-12-31WarningsExact 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