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 FDA2026-10-15
excluded packagepackage49527-06149527-061-01IInactivated by FDA2026-10-15

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 12 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
application number: M006
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
application number: M006
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact 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