FDA.reportPublic FDA data

b pure Blemish Concealer for Acne Prone Skin Nude

Product NDC
80684-108
11-digit product format
806840108
Labeler code
80684
Product ID
80684-108_1a9de2b4-a5e4-63b2-e063-6394a90af383
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
SALICYLIC ACID
Active strength
5 mg/g
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
b pure Blemish Concealer for Acne Prone Skin Nude
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/g

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
248684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76e91277-1fb4-490b-b351-39d626bc1fc2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-108-00b pure Blemish Concealer for Acne Prone Skin Nude1.4 g in 1 TUBECREAM1.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-108B PURE BLEMISH CONCEALER FOR ACNE PRONE SKIN NUDE (SALICYLIC ACID) CREAM [FOURSTAR GROUP USA, INC.]1Current NDC, 1 package rows20240901_76e91277-1fb4-490b-b351-39d626bc1fc2.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 15 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peace Out Acne SerumSALICYLIC ACIDPeace Out LLC.7cd68513-0470-4409-82d0-619c97e69ff42026-01-14WarningsExact identifier
application number: M006
MEDPURA Benzoyl PeroxideBENZOYL PEROXIDEAkron Pharma Inc.1b051efe-054b-42a0-915a-b87885bd3c542026-01-13WarningsExact identifier
application number: M006
END-ZITSULFURABBE Laboratories, Inc.afed5e8e-324c-44c6-abf6-72938376a4b22026-01-13WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCc4775032-9723-4208-8a42-145f2b4da1c82026-01-12WarningsExact identifier
application number: M006
BHA CLEANSER 2%SALICYLIC ACIDSkinfix, Inc.ceccb599-ff9e-fc87-e053-2a95a90a411a2026-01-12WarningsExact identifier
application number: M006
ACNE SPOT TREATMENT 2% BHASALICYLIC ACIDSkinfix, Inc.ceccea68-07d8-0903-e053-2995a90ab2b72026-01-12WarningsExact identifier
application number: M006
Sulfo loSULFUR 3% SOAP BARCrown Laboratories89577417-76a0-cb04-e053-2995a90a57332026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories1660f219-e789-91f1-e063-6294a90a76642026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratoriesff09cbab-304b-4da9-e053-6394a90ae6002026-01-12WarningsExact identifier
application number: M006
PanOxyl Clarifying ExfoliantSALICYLIC ACIDCrown Laboratories, Inc.faa6576c-2af2-d86b-e053-6294a90ada2d2026-01-12WarningsExact identifier
application number: M006
PanOxylBENZOYL PEROXIDECrown Laboratories7b301b94-3cc8-b05b-e053-2991aa0aa5612026-01-12WarningsExact identifier
application number: M006
PanOxyl Acne Gel WashSALICYLIC ACIDCrown Laboratories, Inc.39712bb8-3d4e-29b3-e063-6394a90a95b82026-01-12WarningsExact identifier
application number: M006
Proactiv Clean Mineral Acne CleanserSULFURAlchemee, LLC380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b2026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Acne Clearing HydratorSALICYLIC ACIDAlchemee, LLC33ac397c-55af-4a50-b5ce-80f8a88015812026-01-07WarningsExact identifier
application number: M006
Proactiv CLEAR ZONE BODY PADSSALICYLIC ACIDAlchemee, LLCcf9e5536-08f6-4bbd-9e09-2e9a0c768ed92026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Complexion Perfecting HydratorSALICYLIC ACIDAlchemee, LLCc9b91b61-738e-474e-927f-0806264c739e2026-01-07WarningsExact identifier
application number: M006
Proactiv plus Pore Targeting TreatmentBENZOYL PEROXIDEAlchemee, LLC12f2eeab-d258-4eb1-8fe2-784c51c2e4cc2026-01-07WarningsExact identifier
application number: M006
Proactiv Plus Retexturizing TonerSALICYLIC ACIDAlchemee, LLC7c211ff7-920f-407b-ad8d-60d14803b8572026-01-07WarningsExact identifier
application number: M006
Proactiv Clarifying NightSALICYLIC ACIDAlchemee, LLC8b81b4e5-f2fc-45a1-923a-7c326529d68b2026-01-07WarningsExact identifier
application number: M006
Proactiv Emergency Blemish ReliefBENZOYL PEROXIDEAlchemee, LLC72bb45ca-3f68-47be-928e-755cc66419d92026-01-07WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248684salicylic acid 0.5 % Topical CreamPSN76e91277-1fb4-490b-b351-39d626bc1fc21
248684salicylic acid 5 MG/ML Topical CreamSCD76e91277-1fb4-490b-b351-39d626bc1fc21
248684salicylic acid 0.5 % Topical CreamSY76e91277-1fb4-490b-b351-39d626bc1fc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-108-00806840108001.4 g in 1 TUBE (80684-108-00) 1.4 g2024-09-01NoNoCurrent