FDA.reportPublic FDA data

Acne Advanced Treatment System

Product NDC
15751-3000
Requested package NDC
15751-3000-3
11-digit product format
157513000
Labeler code
15751
Product ID
15751-3000_0b8238aa-5560-5d63-e063-6294a90a9a23
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
KIT
Labeler
Eminence Organic Skin Care Ltd.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-01
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
Acne Advanced Treatment System
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248684Internal RxNorm lookup
417424Internal RxNorm lookup
1038982Internal RxNorm lookup
2055315Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9acf53a6-10f1-470d-b270-3a0203cf89c0Available 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
15751-3000-3Acne Advanced Treatment System1 in 1 KITKIT16
15751-3010-5Acne Advanced Treatment System150 mL in 1 BOTTLELIQUID150 mL10 mg in 1mL6
15751-3010-5Acne Advanced Treatment System1 in 1 BOXLIQUID10 mg in 1mL6
15751-3020-2Acne Advanced Treatment System60 mL in 1 TUBECREAM60 mL5 mg in 1mL6
15751-3020-2Acne Advanced Treatment System1 in 1 BOXCREAM5 mg in 1mL6
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15751-3000ACNE ADVANCED TREATMENT SYSTEM (SALICYLIC ACID) KIT [EMINENCE ORGANIC SKIN CARE LTD.]6Current NDC, Legacy NDC, 7 package rows20231203_9acf53a6-10f1-470d-b270-3a0203cf89c0.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 46 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
application number: M006
BLAIR and JACK Anti-Bump Acne TreatmentBENZOYL PEROXIDEBlair + Jackaa8df86a-639c-4416-aadf-4b58566ed9f12024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin NudeSALICYLIC ACIDFourstar Group USA, Inc.76e91277-1fb4-490b-b351-39d626bc1fc22024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.764599e5-2ec3-4223-819e-36415fd915f72024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Acne CleanserBENZOYL PEROXIDETopiderm, Inc.00fb1ee5-6076-4980-8507-9e58a96e6a6b2024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Spot TreatmentBENZOYL PEROXIDETopiderm, Inc.dfdb3d8e-4d39-4ce4-851f-80b11972ca9e2024-06-11WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.69bd4f4c-017a-7422-e053-2991aa0aa6552024-06-10WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Rapid Acne TreatmentSULFURL'Oreal USA Products Incd7cc3c06-2f89-4c0b-b121-fdd53638b6252024-06-07WarningsExact identifier
application number: M006
Differin 10% BPO Acne TreatmentBENZOYL PEROXIDEGalderma Laboratories, L.P.05468eab-f239-42cb-9106-055a105f0fa52024-06-06WarningsExact identifier
application number: M006
2.5 Acne MedBENZOYL PEROXIDEFace Reality, Inc.58a7f677-996c-4951-8e5d-b5556244f8002024-06-05WarningsExact identifier
application number: M006
10 Acne MedBENZOYL PEROXIDEFace Reality, Inc.91791905-086f-44cf-9c1a-e9f132c6c11b2024-06-05WarningsExact identifier
application number: M006
Walgreens Oil-Free Acne Wash Salicylic AcidSALICYLIC ACIDWalgreen Company9f311567-caa2-4302-9cf8-8c341917d16e2024-06-03WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne Treatment Acne medicationBENZOYL PEROXIDEWalgreen Company72ca0ddd-9292-48c9-9189-532a1768c9b72024-06-03WarningsExact identifier
application number: M006
Derma E Acne Matte MoisturizerSALICYLIC ACIDderma e48fd8477-b880-4a31-9227-095d38a7eac52024-05-31WarningsExact identifier
application number: M006
LACTO-S ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltdea0c7fda-30a0-48df-8a1b-4d6098c0081e2024-05-31WarningsExact identifier
application number: M006
Derma E Acne Cleansing PadsSALICYLIC ACIDderma ec749a11f-daa1-4d76-b818-cd6509efaceb2024-05-28WarningsExact identifier
application number: M006
ULTA All Clear SERUMSALICYLIC ACIDAPR BEAUTY GROUP INC199a96c1-94b8-3de6-e063-6394a90ab4782024-05-28WarningsExact identifier
application number: M006
Crystal Clear Acne Treatment PadsSALICYLIC ACIDSkin Pharm, LLC0469b1ab-5cfb-416a-b34b-7dc6fef611ff2024-05-22WarningsExact identifier
application number: M006
Anti-Aging Blemish Control Peel PadsSALICYLIC ACIDJune Jacobs Labs, LLC18fa83ab-1712-398c-e063-6394a90a6b792024-05-21WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.efa796e8-62a8-6c20-e053-2a95a90aef6f2024-05-20WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15751-3000-3157513000031 KIT in 1 KIT (15751-3000-3) * 1 TUBE in 1 BOX (15751-3020-2) / 60 mL in 1 TUBE * 1 BOTTLE in 1 BOX (15751-3030-2) / 35 mL in 1 BOTTLE * 1 BOTTLE in 1 BOX (15751-3010-5) / 150 mL in 1 BOTTLE1 kit2018-09-010000-00-00NoNoCurrent