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 24 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR ANTI-ACNE SERUMSALICYLID ACIDSkin Ai, LLC410d1968-6931-7a48-e063-6294a90abb622025-10-13WarningsExact identifier
application number: M006
GENTLE ACNE SERUMSALICYLIC ACIDDrmtlgy, LLCa8e41339-3f3b-44ad-9b2f-1962d5f66f3d2025-10-10WarningsExact identifier
application number: M006
30 day Acne Treatment KitSALICYLIC ACID, BENZOYL PEROXIDECosmetic Enterprises Ltd039ac054-3eb2-5beb-e063-6394a90a561a2025-10-10WarningsExact identifier
application number: M006
Breakout Control BioelementsBENZOYL PEROXIDECosmetic Enterprises Ltd94462332-2169-4ea1-86b3-25ab9646c6e52025-10-10WarningsExact identifier
application number: M006
Anti Bac Acne ClearingBENZOYL PEROXIDECosmetic Enterprise Ltd7f6ee76b-c664-2ec4-e053-2991aa0a94882025-10-10WarningsExact identifier
application number: M006
Clear Acne Body Paulas ChoiceSALICYLIC ACIDCosmetic Enterprises Ltd46cb9ff7-0f8f-457f-b4bb-6f33502243752025-10-10WarningsExact identifier
application number: M006
Clear Exfoliating Solution Paulas ChoiceSALICYLIC ACIDCosmetic Enterprises Ltdf84a2b7e-1e02-450f-b290-b4f6f87cdb7a2025-10-10WarningsExact identifier
application number: M006
Starface Acne Spot TreatmentSALICYLIC ACIDStarface World, Inc.f8cfd5b0-317e-4646-9885-71ecad29ba1c2025-10-07WarningsExact identifier
application number: M006
Skin Bliss MistSALICYLIC ACIDMatrix Beauty LLCde280fa0-f993-4ccc-bc92-4a8311b5e7ee2025-10-07WarningsExact identifier
application number: M006
skinlycious Clear skin complete starter kitSALICYLIC ACIDSkinlycious Pte Ltdab1609b7-a10b-44f3-ab86-a615967b2a572025-10-03WarningsExact identifier
application number: M006
Skinlycious Clear Skin Essentials Starter kitSALICYLIC ACIDSkinlycious Pte Ltdaf2d8318-cbff-4317-adb7-828a92af78682025-10-03WarningsExact identifier
application number: M006
Skinlycious Glow ExfoliantSALICYLIC ACIDSkinlycious Pte Ltd4baa8342-e983-43bb-9864-caf14bff21e32025-10-03WarningsExact identifier
application number: M006
Viaderma Clear Acne TreatmentSALICYLIC ACIDViaDerma Distribution, Inc.aa62d4b5-1e46-41bf-a9b6-69ae005fd79a2025-10-02WarningsExact identifier
application number: M006
Caring Mill Acne Clearing CleanserSALICYLIC ACIDFSA Store Inc. (Caring Mills)4038bf3f-d6b9-48a2-e063-6394a90aea6b2025-10-02WarningsExact identifier
application number: M006
Killa Extra Strength 2 packSALICYLIC ACIDZitSticka, Inc.fc9922ba-5164-5837-e053-6294a90a3de52025-10-01WarningsExact identifier
application number: M006
Acne Toner SerumSALICYLIC ACIDDime Beauty Co, LLCe5c35684-e8b5-70fd-e053-2a95a90aedae2025-10-01WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACIDDime Beauty Co, LLCf7fd3f24-7c27-b45b-e053-6394a90a50ae2025-10-01WarningsExact identifier
application number: M006
Creamy Foam CleanserSALICYLIC ACIDDime Beauty Co, LLCe39f41ed-0909-9f0e-e053-2995a90ab36a2025-10-01WarningsExact identifier
application number: M006
DETOX DROPS ACNE TONERACNE TONERKENDO HOLDINGS INC.35bcdb22-550e-b27c-e063-6294a90a2e5b2025-09-30WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne ExfoliantSALICYLIC ACIDKenvue Brands LLC3f90696e-1ece-78be-e063-6294a90a5c6a2025-09-26WarningsExact 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