FDA.reportPublic FDA data

Acne Advanced Clarifying Hydrator

Product NDC
15751-3030
11-digit product format
157513030
Labeler code
15751
Product ID
15751-3030_0c0aef9b-7255-0f3d-e063-6394a90aa271
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Eminence Organic Skin Care Ltd.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-01
Substance
SALICYLIC ACID
Active strength
10 mg/mL
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
Acne Advanced Clarifying Hydrator
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

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
417424Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b710cc36-f589-4116-a0a2-c6966ebebbf2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15751-3030-2Acne Advanced Treatment System35 mL in 1 BOTTLECREAM35 mL10 mg in 1mL6
15751-3030-2Acne Advanced Treatment System1 in 1 BOXCREAM10 mg in 1mL6
15751-3030-2Acne Advanced Clarifying Hydrator1 in 1 BOXCREAM15
15751-3030-2Acne Advanced Clarifying Hydrator35 mL in 1 BOTTLECREAM355
15751-3030-6Acne Advanced Clarifying Hydrator3 mL in 1 PACKETCREAM35
15751-3030-9Acne Advanced Clarifying Hydrator55 mL in 1 BOTTLECREAM555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15751-3030ACNE ADVANCED TREATMENT SYSTEM (SALICYLIC ACID) KIT [EMINENCE ORGANIC SKIN CARE LTD.]6Current NDC, Legacy NDC20231203_9acf53a6-10f1-470d-b270-3a0203cf89c0.zip
15751-3030ACNE ADVANCED CLARIFYING HYDRATOR (SALICYLIC ACID) CREAM [EMINENCE ORGANIC SKIN CARE LTD.]5Current NDC, Legacy NDC, 4 package rows20231210_b710cc36-f589-4116-a0a2-c6966ebebbf2.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 53 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asepxia Charcoal Acne BarSALICYLIC ACIDGenomma Lab USAf727d947-fa91-47ae-8ea5-948afc9e5ba82023-11-06WarningsExact identifier
application number: M006
Asepxia Oil-Free Acne BarSALICYLIC ACIDGenomma Lab USA0b3a9224-f250-45e9-a1fe-a54940c6f93b2023-11-06WarningsExact identifier
application number: M006
Asepxia Softening Acne BarSALICYLIC ACIDGenomma Lab USA9cf65052-b21a-42af-b45a-6a6db36fbb452023-11-06WarningsExact identifier
application number: M006
Asepxia Scrub Acne BarSALICYLIC ACIDGenomma Lab USA361a0b50-360e-4d9b-9780-16b02a2bee3c2023-11-06WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Pore Purifying TonerSALICYLIC ACIDFarmasi US LLCb8dcfaab-8c55-f23d-e053-2a95a90a8a012023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCb8dd3370-fe03-f0f4-e053-2a95a90ab8132023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Blemish Control SerumSALICYLIC ACIDFarmasi US LLCb8dd63d7-4ff2-60bc-e053-2a95a90ad16c2023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCde493e30-d10c-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M006
SERIOUS SKINCARE Continuously Clear Clearz ItBENZOYL PEROXIDEFlageoli Limitedaf4c68ef-89a8-479a-a7b1-9b005193383e2023-11-05WarningsExact identifier
application number: M006
HUMANE ACNE WASHBENZOYL PEROXIDEApprendista, LLC1d25fb25-a3d2-4c6b-a975-be7b90b702652023-11-05WarningsExact identifier
application number: M006
VIE NATURELLE ACNE BODYBENZOYL PEROXIDETNT PRO SERIES0278251d-bcf1-4177-8a57-163bd0f2df002023-11-05WarningsExact identifier
application number: M006
enfuselle Acne ClarifyingSALICYLIC ACIDShaklee Corporationdd429a9b-5c2d-4310-8506-6487b02e38802023-11-03WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Exfoliating tonerSALICYLIC ACIDPeach & Lily Inc.ba70ed1c-83cb-5eaa-e053-2a95a90a92cc2023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Clarifying CleanserSALICYLIC ACIDPeach & Lily, Inc.ba70f2b9-7a34-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Oil Acne Free MoisturizerSALICYLIC ACIDPeach & Lily, Inc.ba70e7cf-af86-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
application number: M006
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
application number: M006
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
application number: M006
Equate Beauty Quick Action Pads Salicylic Acid Acne TreatmentSALICYLIC ACIDBath Concept Cosmetics (Dongguan) Co., Ltdc94e85a7-b799-b70d-e053-2a95a90aaee22023-10-26WarningsExact identifier
application number: M006
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore RefresherSALICYLIC ACIDAccess Business Group LLCa9e26804-7989-41d2-8506-c4b65ca385b72023-10-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055315{1 (150 ML) (salicylic acid 10 MG/ML Medicated Liquid Soap) / 1 (35 ML) (salicylic acid 10 MG/ML Topical Cream) / 1 (60 ML) (salicylic acid 5 MG/ML Topical Cream) } PackGPCK9acf53a6-10f1-470d-b270-3a0203cf89c06
248684salicylic acid 0.5 % Topical CreamPSN9acf53a6-10f1-470d-b270-3a0203cf89c06
1038982salicylic acid 1 % Medicated Liquid SoapPSN9acf53a6-10f1-470d-b270-3a0203cf89c06
2055315salicylic acid 1 % Medicated Liquid Soap (150 ML) / salicylic acid 1 % Topical Cream (35 ML) / salicylic acid 0.5 % Topical Cream (60 ML) PackPSN9acf53a6-10f1-470d-b270-3a0203cf89c06
417424salicylic acid 1 % Topical CreamPSN9acf53a6-10f1-470d-b270-3a0203cf89c06
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD9acf53a6-10f1-470d-b270-3a0203cf89c06
417424salicylic acid 10 MG/ML Topical CreamSCD9acf53a6-10f1-470d-b270-3a0203cf89c06
248684salicylic acid 5 MG/ML Topical CreamSCD9acf53a6-10f1-470d-b270-3a0203cf89c06
248684salicylic acid 0.5 % Topical CreamSY9acf53a6-10f1-470d-b270-3a0203cf89c06
1038982salicylic acid 1 % Medicated Liquid SoapSY9acf53a6-10f1-470d-b270-3a0203cf89c06
417424salicylic acid 1 % Topical CreamSY9acf53a6-10f1-470d-b270-3a0203cf89c06
417424salicylic acid 1 % Topical CreamPSNb710cc36-f589-4116-a0a2-c6966ebebbf25
417424salicylic acid 10 MG/ML Topical CreamSCDb710cc36-f589-4116-a0a2-c6966ebebbf25
417424salicylic acid 1 % Topical CreamSYb710cc36-f589-4116-a0a2-c6966ebebbf25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15751-3030-2157513030021 BOTTLE in 1 BOX (15751-3030-2) / 35 mL in 1 BOTTLE1 bottle2018-09-010000-00-00NoNoCurrent
15751-3030-6157513030063 mL in 1 PACKET (15751-3030-6) 3 ml2018-09-010000-00-00YesNoCurrent
15751-3030-91575130300955 mL in 1 BOTTLE (15751-3030-9) 55 ml2018-09-010000-00-00NoNoCurrent