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 42 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Advanced Acne Spot TreatmentSALICYLIC ACIDCVS PHARMACYd4f1c74f-ee26-0e43-e053-2995a90a29722024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Rescue Skin-Clearing Loose Foundation Fair 1CSALICYLIC ACIDOrveon Global US LLC139e2d26-76de-4ad3-a6e6-7465bf5987ad2024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Remedy Acne Treatment Gelee CleanserSALICYLIC ACIDOrveon Global US LLCb3060c4a-8f6f-4dea-a16c-fdc169ca4d112024-10-22WarningsExact identifier
application number: M006
RETINOID CLEARINGSALICYLIC ACIDDermalogica, LLC.fa77fdf4-873e-424e-8d89-05585615b1f42024-10-21WarningsExact identifier
application number: M006
La Roche Posay Effaclar Dermatological Acne System 3 Step Acne RoutineBENZOYL PEROXIDE AND SALICYLIC ACIDL'Oreal USA Products Incfa21d384-6867-442f-8537-290a691e25202024-10-21WarningsExact identifier
application number: M006
ACNE WASHSALICYLIC ACIDHarmon Stores Inc.9d0451a5-c8f9-4d0f-9928-fbc90ef134fe2024-10-21WarningsExact identifier
application number: M006
Peace Out Acne Day DotSALICYLIC ACIDPeace Out LLC.ec1a2ee4-f92b-b363-e053-2a95a90a5ccc2024-10-18WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.3744aef3-d92e-46a6-8c89-0fe5f0791a682024-10-18WarningsExact identifier
application number: M006
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne TreatmentBENZOYL PEROXIDECVS PHARMACYfa402202-1750-e6eb-e053-6294a90a4e632024-10-17WarningsExact identifier
application number: M006
Meijer Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDMEIJER DISTRIBUTION, INC8f8754d8-85ff-0e64-e053-2995a90a7c212024-10-16WarningsExact identifier
application number: M006
KROGER CLARIFY CARE ACNE WASHSALICYLIC ACIDTHE KROGER COMPANYc8eaada4-142f-4e64-e053-2995a90a98442024-10-15WarningsExact identifier
application number: M006
H.E.B. Oil Free Daily Acne ScrubSALICYLIC ACIDH.E.Bdf2b8b89-e4d1-4745-e053-2995a90aed012024-10-15WarningsExact identifier
application number: M006
Walgreens Acne Control GelSALICYLIC ACIDWALGREEN COMPANYffc4c35b-1390-951b-e053-6294a90a1b112024-10-14WarningsExact identifier
application number: M006
Walgreens Maximum Strength Tinted Acne Spot Treatment CreamBENZOYL PEROXIDEWALGREEN COMPANYfa3f4356-ff1c-5ff1-e053-6394a90a72792024-10-14WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne GelBENZOYL PEROXIDEWALGREEN COMPANYfd7dd2eb-03a6-ef1f-e053-6294a90a85572024-10-14WarningsExact identifier
application number: M006
WALGREENS ALL PURPOSE PSORIASIS WASHSALICYLIC ACIDWALGREEN COMPANYa9e00927-5bc2-c6da-e053-2a95a90afa5a2024-10-14WarningsExact identifier
application number: M006
WALGREENS DAILY REPAIR PSORIASIS MOISTURIZERSALICYLIC ACIDWALGREEN COMPANYa9e07cd1-b788-b9bc-e053-2995a90a897d2024-10-14WarningsExact identifier
application number: M006
WALGREENS APRICOT SCRUB ACNE TREATMENTSALICYLIC ACIDWALGREEN COMPANYc0081097-424c-4ebf-ae9e-750650e67e692024-10-14WarningsExact identifier
application number: M006
Up and Up Acne WashSALICYLIC ACIDTARGET CORPORATION93410bbe-4dd7-12db-e053-2995a90a2c962024-10-14WarningsExact identifier
application number: M006
Target Up and Up Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDTARGET CORPORATIONbaec4311-d07e-bd70-e053-2a95a90ad4042024-10-14WarningsExact 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