FDA.reportPublic FDA data

enfuselle Acne Clarifying

Product NDC
59899-002
11-digit product format
598990002
Labeler code
59899
Product ID
59899-002_09495cdc-6fd1-9f95-e063-6394a90a7d5c
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
LOTION
Route
TOPICAL
Labeler
Shaklee Corporation
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-08
Substance
SALICYLIC ACID
Active strength
5 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
enfuselle Acne Clarifying
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 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
199134Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd429a9b-5c2d-4310-8506-6487b02e3880Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59899-002-01enfuselle Acne Clarifying29 mL in 1 TUBELOTION2910
59899-002-01enfuselle Acne Clarifying1 in 1 CARTONLOTION110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
CETEARYL ETHYLHEXANOATEINACTIVE INGREDIENT9M64UO4C25ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
GALACTOARABINANINACTIVE INGREDIENTSL4SX1O487ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
MANUKA OILINACTIVE INGREDIENTM6QU9ZUH2XENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
NASTURTIUM OFFICINALEINACTIVE INGREDIENTYH89GMV676ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) CREAM [SHAKLEE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59899-002ENFUSELLE ACNE CLARIFYING (SALICYLIC ACID) LOTION [SHAKLEE CORPORATION]10Current NDC, Legacy NDC, 2 package rows20231104_dd429a9b-5c2d-4310-8506-6487b02e3880.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 52 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
application number: M006
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
application number: M006
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
application number: M006
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
application number: M006
MD-Acne Body Acne TreatmentBENZOYL PEROXIDEMD Algorithms Inc.97981e9b-d56a-42f6-a75f-647b4732021e2023-11-11WarningsExact identifier
application number: M006
ACNE THERAPYBENZOYL PEROXIDEmenScience Androceuticals, LLC4dec259d-200e-44f2-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M006
HUMANE Acne Spot TreatmentBENZOYL PEROXIDEApprendista, LLCceeb398e-c516-45e4-a21c-cbecf6206fcc2023-11-11WarningsExact identifier
application number: M006
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
application number: M006
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
application number: M006
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
application number: M006
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
application number: M006
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
application number: M006
ACNE FORTE Acne Treatment CreamBENZOYL PEROXIDEGSCM Ventures Inc. DBA Revitolc29ed6c1-b8ad-4131-a94c-379f16ab2ee52023-11-10WarningsExact identifier
application number: M006
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
application number: M006
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
application number: M006
Asepxia Neutral Acne BarSALICYLIC ACIDGenomma Lab USAb3995e68-d364-4d96-8148-b456087b42972023-11-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199134salicylic acid 0.5 % Topical LotionPSNdd429a9b-5c2d-4310-8506-6487b02e388010
199134salicylic acid 5 MG/ML Topical LotionSCDdd429a9b-5c2d-4310-8506-6487b02e388010
199134salicylic acid 0.5 % Topical LotionSYdd429a9b-5c2d-4310-8506-6487b02e388010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59899-002-01598990002011 TUBE in 1 CARTON (59899-002-01) / 29 mL in 1 TUBE1 tube2013-08-080000-00-00NoNoCurrent