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 38 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TREAT SO DEEP ACNE-FIGHTING TREATMENTSALICYLIC ACIDASPIRE BRANDS INCd18b4f15-9ea1-4d76-a1e3-a0be1c5bb58a2024-12-06WarningsExact identifier
application number: M006
Oxy Maximum Strength Rapid Spot TreatmentOXY MAXIMUM STRENGTH RAPID SPOT TREATMENTThe Mentholatum Company28886273-a71a-46ea-e063-6394a90ac11d2024-12-05WarningsExact identifier
application number: M006
Dermaclear Spot TreatmentBENZOYL PEROXIDEAllure Labs Inc45a93c47-552f-4660-a37c-7a8cceac2d8e2024-12-05WarningsExact identifier
application number: M006
DermaClear PadsSALICYLIC ACIDAllure Labs0c6624fd-88f9-402c-8ac2-bc278242b4842024-12-05WarningsExact identifier
application number: M006
DermaClear BHA Spot TreatmentSALICYLIC ACIDAllure Labsb629cb05-548e-4d60-e053-2a95a90aeefb2024-12-05WarningsExact identifier
application number: M006
Acne Treatment Maximum StrengthSALICYLIC ACIDYoung Living Essential Oils, LC756a52ff-161d-4b6e-933b-49bce885d9982024-12-04WarningsExact identifier
application number: M006
DermaClear SerumSALICYLIC ACIDAllure Labs Inc487a7d1c-0f98-4d36-bfe9-c12bcda8d0b32024-12-04WarningsExact identifier
application number: M006
Dermaclear MaskSALICYLIC ACIDAllure Labs Inc,9429f477-a916-49c9-bf04-1cf591af5c7f2024-12-04WarningsExact identifier
application number: M006
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact 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