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 35 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Breakout Clearing Foaming WashSALICYLIC ACIDDermalogicae55d212b-7687-47fd-86ec-f8709804dd042024-12-24WarningsExact identifier
application number: M006
BREAKOUT CLEARING BOOSTERSALICYLIC ACIDDermalogica, Inc.6a3bb679-8a03-4f0a-950e-5a40f2b5b70e2024-12-24WarningsExact identifier
application number: M006
AGE Bright Clearing SerumSALICYLIC ACIDDermalogica, Incd5291f67-3329-42c7-b9c2-9bae797ecb5b2024-12-24WarningsExact identifier
application number: M006
Maybelline Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Blemish Clearing CleanserSALICYLIC ACIDLOreal USA Products Inc4e03b29c-6d1c-473c-91b9-291a0cb523fb2024-12-23WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial AstringentSALICYLIC ACID 2%Derma Care Research Labs, LLCd692e7e2-11c7-7b4a-e053-2a95a90ae17b2024-12-20WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial CleanserSALICYLIC ACID 2%Derma Care Research Labs, LLCd6e59f75-cd3d-3fc4-e053-2a95a90abf4c2024-12-20WarningsExact identifier
application number: M006
Monat Acne TreatmentBENZOYL PEROXIDEMonat Global Corpf76eb53e-643d-52cf-e053-6394a90a6e8f2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 10% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7083b69-fed4-d497-e053-2a95a90a1a8c2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
application number: M006
Detox Drops 2% Salicylic Acid Acne TonerSALICYLIC ACIDCOSMAX USA, CORPORATION2999c85e-cb4b-719e-e063-6394a90a0f282024-12-19WarningsExact identifier
application number: M006
OXY 3 in 1 Acne PadsSALICYLIC ACIDThe Mentholatum Company5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a2024-12-17WarningsExact identifier
application number: M006
Phisoderm Clear Confidence Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company2a51c80a-27e8-44d3-b06f-b2a9081c57962024-12-17WarningsExact identifier
application number: M006
Oxy 10 VanishingBENZOYL PEROXIDEThe Mentholatum Companyd499b69a-25aa-4e3d-a07e-a774bc0d65f12024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Clay Acne WashSALICYLIC ACIDThe Mentholatum Companyeb2a0e0b-2ed5-4c14-8607-0b61ca48c4952024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Ash Acne Face WashSALICYLIC ACIDThe Mentholatum Company6d768d3d-c1df-4a85-9c76-7f7a2ec90b2d2024-12-17WarningsExact identifier
application number: M006
Oxy 10 TintedBENZOYL PEROXIDEThe Mentholatum Company0ceee85d-dc8c-49b3-9b44-8fe60022c2432024-12-17WarningsExact identifier
application number: M006
Oxy 5 VanishingBENZOYL PEROXIDEThe Mentholatum Companyc4aa0fff-6e4a-47a8-9adc-ac2426f8292e2024-12-17WarningsExact identifier
application number: M006
Oxy 5 TintedBENZOYL PEROXIDEThe Mentholatum Company94c863f0-711a-4807-ba1f-a56c7e3f86702024-12-17WarningsExact identifier
application number: M006
Phisoderm Anti Blemish Body WashSALICYLIC ACIDThe Mentholatum Companybba14225-2970-4678-b5a1-78ed94c389d92024-12-17WarningsExact 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