FDA.reportPublic FDA data

blackhead solutions self-heating blackhead extractor acne medication

Product NDC
49527-061
11-digit product format
495270061
Labeler code
49527
Product ID
49527-061_f1d9957a-d2df-7ef5-e053-2a95a90a7488
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic acid
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-08-30
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-061IInactivated by FDA2026-10-16
excluded packagepackage49527-06149527-061-01IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-061-012022-08-04C16284748780-1e4f33bdf-9f7a-d8a0-e053-dadaa90a6e4eblackhead solutions self-heating blackhead extractor acne medication
49527-061-012022-07-29C16284748780-1e4f33bdf-9f7a-d8a0-e053-dadaa90a6e4eblackhead solutions self-heating blackhead extractor acne medication

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-061-01blackhead solutions self-heating blackhead extractor acne medication20 mL in 1 TUBE, WITH APPLICATORCREAM208
49527-061-01blackhead solutions self-heating blackhead extractor acne medication1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-061BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION (SALICYLIC ACID) CREAM [CLINIQUE LABORATORIES LLC]8Legacy NDC, 2 package rows20241226_e36ba6f7-5d75-4a12-af03-2a4b60a712e4.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 37 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxy Total Care Creamy Facial CleanserSALICYLIC ACIDThe Mentholatum Companyaed37bff-6723-4865-aa9b-10e7adcceeea2024-12-13WarningsExact identifier
application number: M006
OXY Sensitive Face Wash Maximum SoothingBENZOYL PEROXIDEThe Mentholatum Companyc02ff802-fe48-41fb-a9dd-6a74da334a522024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Daily Gel Face WashSALICYLIC ACIDThe Mentholatum Companyaccafe6b-d350-4539-a39d-a9ee9a4fee292024-12-13WarningsExact identifier
application number: M006
OXY 10 Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company35dbfe37-992d-4c9c-a4be-707d32370c762024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Body WashSALICYLIC ACIDThe Mentholatum Companye4c88ea1-5311-4e1f-a9ac-facef02b9c042024-12-13WarningsExact identifier
application number: M006
Stridex XL Face and Body PadsSALICYLIC ACIDBlistex Inced459e80-22cc-40ef-862c-1adf82da23772024-12-13WarningsExact identifier
application number: M006
Stridex EssentialSALICYLIC ACIDBlistex Inc994b890a-8a82-4ce2-a4a4-bde2360cc2592024-12-13WarningsExact identifier
application number: M006
Stridex SensitiveSALICYLIC ACIDBlistex Inc843d3424-bd6c-44aa-976b-63c9da15014e2024-12-12WarningsExact identifier
application number: M006
Clean and Clear blackhead eraser scrubSALICYLIC ACIDKenvue Brands LLC20197516-ce6b-4ae9-81ee-fac7636f844a2024-12-11WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLCa0c9c479-4fc1-43e4-97a2-e6095fc175592024-12-11WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Daily ScrubSALICYLIC ACIDKenvue Brands LLC398e39ea-5119-4094-a1be-09eb7f0d23a22024-12-11WarningsExact identifier
application number: M006
Sulfur Spot TreatmentSULFURFace Reality, Inc921e948d-a8c7-4527-9257-4b91dee8fcff2024-12-09WarningsExact identifier
application number: M006
Acne Oil Control PrimerSALICYLIC ACIDAllure Labsdb9b5de2-c07c-0b21-e053-2995a90ae9a92024-12-09WarningsExact identifier
application number: M006
Clear Cell Clarifying AcneBENZOYL PEROXIDEAllure Labsda87cbbf-12ca-3224-e053-2995a90a25e42024-12-09WarningsExact identifier
application number: M006
Daily Leave on Acne Treatment MaskBENZOYL PEROXIDEAllure Labsdbb27841-7c9e-6d00-e053-2a95a90a6ab12024-12-09WarningsExact identifier
application number: M006
Blemish Control BarSALICYLIC ACIDCP Skin Health Group, Inc.1b1ed540-4a9d-4716-95d2-6c8229a2afc92024-12-09WarningsExact identifier
application number: M006
SCRUB SO CLEAN ACNE-FIGHTING SUPER SCRUBSALICYLIC ACIDASPIRE BRANDS INCe33629fb-be88-4de2-871d-10090ca3a8f42024-12-06WarningsExact identifier
application number: M006
CLEAN GETAWAY BAGSALICYLIC ACIDASPIRE BRANDS INC16d2264b-e00b-4a3a-9b52-2bf4ca33a73a2024-12-06WarningsExact identifier
application number: M006
SO TOTALLY CLEAN DEEP PORE CLEANSERSALICYLIC ACIDASPIRE BRANDS INCdb47a78a-2694-4c21-af6e-d787a5e0fbb92024-12-06WarningsExact identifier
application number: M006
START SO FRESHSALICYLIC ACIDASPIRE BRANDS INC85f4af7d-ae9c-45cb-a7d7-5e1189f5471b2024-12-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417424salicylic acid 1 % Topical CreamPSNe36ba6f7-5d75-4a12-af03-2a4b60a712e48
417424salicylic acid 10 MG/ML Topical CreamSCDe36ba6f7-5d75-4a12-af03-2a4b60a712e48
417424salicylic acid 1 % Topical CreamSYe36ba6f7-5d75-4a12-af03-2a4b60a712e48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49527-061-01495270061011 BOTTLE, WITH APPLICATOR in 1 CARTON (49527-061-01) > 20 mL in 1 BOTTLE, WITH APPLICATOR2018-08-300000-00-00NoNoCurrent