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 FDA2026-10-20
excluded packagepackage49527-06149527-061-01IInactivated by FDA2026-10-20

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 53 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asepxia Charcoal Acne BarSALICYLIC ACIDGenomma Lab USAf727d947-fa91-47ae-8ea5-948afc9e5ba82023-11-06WarningsExact identifier
application number: M006
Asepxia Oil-Free Acne BarSALICYLIC ACIDGenomma Lab USA0b3a9224-f250-45e9-a1fe-a54940c6f93b2023-11-06WarningsExact identifier
application number: M006
Asepxia Softening Acne BarSALICYLIC ACIDGenomma Lab USA9cf65052-b21a-42af-b45a-6a6db36fbb452023-11-06WarningsExact identifier
application number: M006
Asepxia Scrub Acne BarSALICYLIC ACIDGenomma Lab USA361a0b50-360e-4d9b-9780-16b02a2bee3c2023-11-06WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Pore Purifying TonerSALICYLIC ACIDFarmasi US LLCb8dcfaab-8c55-f23d-e053-2a95a90a8a012023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCb8dd3370-fe03-f0f4-e053-2a95a90ab8132023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Blemish Control SerumSALICYLIC ACIDFarmasi US LLCb8dd63d7-4ff2-60bc-e053-2a95a90ad16c2023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCde493e30-d10c-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M006
SERIOUS SKINCARE Continuously Clear Clearz ItBENZOYL PEROXIDEFlageoli Limitedaf4c68ef-89a8-479a-a7b1-9b005193383e2023-11-05WarningsExact identifier
application number: M006
HUMANE ACNE WASHBENZOYL PEROXIDEApprendista, LLC1d25fb25-a3d2-4c6b-a975-be7b90b702652023-11-05WarningsExact identifier
application number: M006
VIE NATURELLE ACNE BODYBENZOYL PEROXIDETNT PRO SERIES0278251d-bcf1-4177-8a57-163bd0f2df002023-11-05WarningsExact identifier
application number: M006
enfuselle Acne ClarifyingSALICYLIC ACIDShaklee Corporationdd429a9b-5c2d-4310-8506-6487b02e38802023-11-03WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Exfoliating tonerSALICYLIC ACIDPeach & Lily Inc.ba70ed1c-83cb-5eaa-e053-2a95a90a92cc2023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Clarifying CleanserSALICYLIC ACIDPeach & Lily, Inc.ba70f2b9-7a34-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Oil Acne Free MoisturizerSALICYLIC ACIDPeach & Lily, Inc.ba70e7cf-af86-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
application number: M006
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
application number: M006
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
application number: M006
Equate Beauty Quick Action Pads Salicylic Acid Acne TreatmentSALICYLIC ACIDBath Concept Cosmetics (Dongguan) Co., Ltdc94e85a7-b799-b70d-e053-2a95a90aaee22023-10-26WarningsExact identifier
application number: M006
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore RefresherSALICYLIC ACIDAccess Business Group LLCa9e26804-7989-41d2-8506-c4b65ca385b72023-10-21WarningsExact 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