FDA.reportPublic FDA data

Tula Skincare Breakout Star Lightweight Acne Moisturizer

Product NDC
84126-229
11-digit product format
841260229
Labeler code
84126
Product ID
84126-229_4c9c41c7-6fcd-61fa-e063-6294a90a4168
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage84126-22984126-229-50DDiscontinued by firm2026-10-12

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
Tula Skincare Breakout Star Lightweight Acne Moisturizer
Listing expiration
2027-12-31

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
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bd1d5f5-1b3c-5e82-e063-6394a90a6454Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-229-15Tula Skincare Breakout Star Lightweight Acne Moisturizer15 mL in 1 TUBECREAM152
84126-229-50Tula Skincare Breakout Star Lightweight Acne Moisturizer50 mL in 1 BOTTLE, PUMPCREAM502
84126-229-50Tula Skincare Breakout Star Lightweight Acne Moisturizer1 in 1 CARTONCREAM12
84126-229-51Tula Skincare Breakout Star Lightweight Acne Moisturizer50 mL in 1 BOTTLE, PUMPCREAM502

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 21 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne CleanserSALICYLIC ACIDCurology44730f63-1f22-27a5-e063-6294a90a63c22025-11-25WarningsExact identifier
application number: M006
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
application number: M006
Shaant Pore Purifying Face ScrubSALICYLIC ACIDCodex Labs Corporationd806e749-ea2c-4db4-af65-a1f8afce1b0e2025-11-21WarningsExact identifier
application number: M006
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
application number: M006
Shaant Hydrating Body ScrubSALICYLIC ACIDCodex Labs Corporation64a176a1-7dc4-44f8-8b3d-4349460a17b02025-11-21WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.4401fff2-725f-8ff0-e063-6294a90ae9ba2025-11-20WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.440a3a73-7136-f8b2-e063-6394a90a744d2025-11-20WarningsExact identifier
application number: M006
Acne Defense Spot Treatment Merle NormanSALICYLIC ACIDMerle Norman Cosmetics, Incc6296d3a-fabe-4a8f-91e8-cac2ae6ff9262025-11-18WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming and Soothing Clay MaskSALICYLIC ACIDTHG Beauty USA LLC23a3d093-e89b-ddaf-e063-6394a90aaa6a2025-11-14WarningsExact identifier
application number: M006
Daily MedsSALICYLIC ACIDBioelements, Inc.3ffb6cd0-c529-4420-8da8-de52838d8a642025-11-14WarningsExact identifier
application number: M006
Naturium Encapsulated Salicylic Acid Moisturizer 0.75%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a4a0de1-6feb-bf9a-e063-6394a90a32d92025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Body 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a5b80fb-caec-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Serum 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a28640e-37f8-9a74-e063-6294a90a15b72025-11-14WarningsExact identifier
application number: M006
Naturium Sulfur Spot Treatment 8%SULFURe.l.f. Cosmetics, Inc0a4a9aed-5eeb-f648-e063-6394a90a1d762025-11-14WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACID ACNE TREATMENTCosMedical Technologies23bd8842-5237-4131-e054-00144ff8d46c2025-11-13WarningsExact identifier
application number: M006
Overnight Spot TreatmentACNE TREATMENTCosMedical Technologies23bde802-d84a-1ecc-e054-00144ff88e882025-11-13WarningsExact identifier
application number: M006
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSN4bd1d5f5-1b3c-5e82-e063-6394a90a64542
317152salicylic acid 20 MG/ML Topical CreamSCD4bd1d5f5-1b3c-5e82-e063-6394a90a64542
317152salicylic acid 2 % Topical CreamSY4bd1d5f5-1b3c-5e82-e063-6394a90a64542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-229-158412602291515 mL in 1 TUBE (84126-229-15) 15 ml2025-06-01NoNoCurrent
84126-229-508412602295050 mL in 1 BOTTLE, PUMP50 mlHistorical
84126-229-518412602295150 mL in 1 BOTTLE, PUMP (84126-229-51) 50 ml2025-06-01NoNoCurrent