FDA.reportPublic FDA data

Proactiv Clean Acne Clearing Hydrator

Product NDC
11410-458
11-digit product format
114100458
Labeler code
11410
Product ID
11410-458_47d25d28-71f6-9f86-e063-6394a90ab328
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Alchemee, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
Substance
SALICYLIC ACID
Active strength
2 mg/100mL
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
Proactiv Clean Acne Clearing Hydrator
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33ac397c-55af-4a50-b5ce-80f8a8801581Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-458-00Proactiv Clean Acne Clearing Hydrator10 mL in 1 TUBEGEL103
11410-458-00Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-05Proactiv Clean Acne Clearing Hydrator30 mL in 1 TUBEGEL303
11410-458-10Proactiv Clean Acne Clearing Hydrator30 mL in 1 TUBEGEL303
11410-458-10Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-15Proactiv Clean Acne Clearing Hydrator1 in 1 BOXGEL13
11410-458-15Proactiv Clean Acne Clearing Hydrator89 mL in 1 TUBEGEL893
11410-458-05Proactiv Clean Kit30 mL in 1 TUBEGEL30 mL in 1002 mg in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11410-458PROACTIV CLEAN ACNE CLEARING HYDRATOR (SALICYLIC ACID) GEL [ALCHEMEE, LLC]2Current NDC, 7 package rows20231129_33ac397c-55af-4a50-b5ce-80f8a8801581.zip
11410-458PROACTIV CLEAN KIT (CLEAN KIT) KIT [ALCHEMEE, LLC]2Current NDC20240821_1d799657-bc9a-b289-e063-6394a90a43c7.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 16 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv Renewing CleanserBENZOYL PEROXIDEAlchemee, LLC85c22f3a-b6c5-44a2-959c-532c6456ec302026-01-07WarningsExact identifier
application number: M006
Proactiv Repairing TreatmentBENZOYL PEROXIDEAlchemee, LLC9bbf6db0-ff80-44d2-b81b-40080ca46b922026-01-07WarningsExact identifier
application number: M006
Proactiv Deep Cleansing WashSALICYLIC ACIDTHE PROACTIV COMPANY LLC4a2bd12d-f166-43cf-b175-d20affc805262026-01-07WarningsExact identifier
application number: M006
Proactiv Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
application number: M006
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
application number: M006
Proactiv Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
application number: M006
Proactivplus Skin Smoothing ExfoliatorBENZOYL PEROXIDEAlchemee, LLCb56b63d6-5635-4fd4-9517-8b08c3cbf9aa2026-01-07WarningsExact identifier
application number: M006
Proactivplus Smoothing BHA CleanserSALICYLIC ACIDAlchemee, LLC14b9a54c-9993-385e-e063-6394a90a27de2026-01-07WarningsExact identifier
application number: M006
Proactiv Blemish Control Body CreamSALICYLIC ACIDAlchemee, LLC164d2c7f-5f1e-d0a8-e063-6294a90a95f22026-01-07WarningsExact identifier
application number: M006
Proactiv Redness Correcting TreatmentSALICYLIC ACIDAlchemee, LLC25ca582d-158f-2c97-e063-6394a90a56582026-01-07WarningsExact identifier
application number: M006
Proactiv Acne Clearing BodySALICYLIC ACIDAlchemee, LLC22559e3a-3ca4-fb38-e063-6394a90ada9e2026-01-07WarningsExact identifier
application number: M006
Proactiv MD KitMD KITAlchemee, LLC1d142dba-145c-fb33-e063-6394a90a88b62026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Beginner BundleCLEAN KITAlchemee, LLC201e1b5e-555a-92c0-e063-6394a90a13602026-01-07WarningsExact identifier
application number: M006
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
application number: M006
Proactiv Solution KitSOLUTIONS KITAlchemee, LLC17f359a0-04a2-d112-e063-6394a90a27352026-01-07WarningsExact identifier
application number: M006
Universal Clarifying PadSALICYLIC ACIDAllure Labs47d3c57c-d6d2-a9e0-e063-6294a90a3b5b2026-01-07WarningsExact identifier
application number: M006
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
application number: M006
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
application number: M006
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046894sulfur 3 % Medicated Liquid SoapPSN1d799657-bc9a-b289-e063-6394a90a43c72
1046894sulfur 30 MG/ML Medicated Liquid SoapSCD1d799657-bc9a-b289-e063-6394a90a43c72
1046894sulfur 3 % Medicated Liquid SoapSY1d799657-bc9a-b289-e063-6394a90a43c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11410-458-00114100458001 TUBE in 1 BOX (11410-458-00) / 10 mL in 1 TUBE1 tube2023-02-01NoNoCurrent
11410-458-051141004580530 mL in 1 TUBE (11410-458-05) 30 ml2023-02-01NoNoCurrent
11410-458-10114100458101 TUBE in 1 BOX (11410-458-10) / 30 mL in 1 TUBE1 tube2023-02-01NoNoCurrent
11410-458-15114100458151 TUBE in 1 BOX (11410-458-15) / 89 mL in 1 TUBE1 tube2023-02-01NoNoCurrent