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 34 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION CaramelSALICYLIC ACIDALMAY2a982e0e-4720-797e-e063-6294a90a43c12024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION MochaSALICYLIC ACIDALMAY2a9807d1-cf87-7096-e063-6394a90afca32024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Natural TanSALICYLIC ACIDALMAY2a981e22-d7d1-311b-e063-6294a90ab25f2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAYc3b57024-120e-390f-e053-2a95a90a6d352024-12-30WarningsExact identifier
application number: M006
Almay Clear Complexion Makeup BuffSALICYLIC ACIDAlmay2a83300a-15f0-365a-e063-6394a90a28d12024-12-30WarningsExact identifier
application number: M006
RETINOL CLEARINGSALICYLIC ACIDDermalogica, LLC.4c20d87c-f3cf-4a40-acec-b0a8bfb9b29c2024-12-30WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula BalmSALICYLIC ACIDL'Oreal USA Products Inc0c902cfa-d98a-42c3-967b-5a7c51a652492024-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHBentley Laboratories, LLCeb7fa2b5-3bdb-436c-8576-1eea29b8d1ff2024-12-27WarningsExact identifier
application number: M006
Acne Control Superclean Body Wash AHA BHA FormulaSALICYLIC ACIDBentley Laboratories, LLC16fd3343-d044-4f6b-af1a-30bc32ce20412024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5726d12c-708c-46e6-a584-9e5c7a544fc82024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Clarifying Exfoliating CleanserSALICYLIC ACIDL'Oreal USA Products Inca0cc4ae7-c266-4321-92e6-a46d560a74b22024-12-27WarningsExact identifier
application number: M006
BRODA AcneSALICYLIC ACIDBentley Laboratories, LLCb7e1f105-8998-46a5-b1ae-85d21790b8162024-12-27WarningsExact identifier
application number: M006
Monat Be Clarified Acne-Clearing MoisturizerSALICYLIC ACIDCosmax Usa, Corporation2984d615-7ed1-46c3-e063-6294a90a1f8a2024-12-26WarningsExact identifier
application number: M006
Nativae Milia Acne SerumSALICYLIC ACIDCDE BRANDS LLCe04cf0a2-bda7-4e5b-9771-769995cf69252024-12-26WarningsExact identifier
application number: M006
Milani Erase Base Blemish Control PrimerSALICYLIC ACIDCosmax Usa, Corporation1b1f1948-2ad9-48d2-9871-6830b2442f432024-12-26WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cleansing PadsSALICYLIC ACID 0.5%The Mentholatum Company2a36b6c5-f518-66f0-e063-6394a90acd402024-12-26WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a385fac-399b-c111-e063-6394a90aefc32024-12-26WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a398c8d-09e6-513b-e063-6294a90ad8572024-12-26WarningsExact identifier
application number: M006
DEEP ACNESULFURDermalogica, LLC.d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f402024-12-26WarningsExact identifier
application number: M006
SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASKSULFURSunday Riley Modern Skincare, LLC35364a71-b011-42f5-9941-4a2f8440808b2024-12-26WarningsExact 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