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 48 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c61e100b-a141-45b3-842b-855be28b02262024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f5c5a2df-11c5-4134-bf1f-b505642164492024-03-20WarningsExact identifier
application number: M006
Blemish Control Dots aloe veraSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.4722ff71-7d9f-4ef2-9f8b-3614e80b864f2024-03-20WarningsExact identifier
application number: M006
Blemish Control DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b2024-03-20WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ca0e6b50-2995-41f8-b944-9f166aac05112024-03-13WarningsExact identifier
application number: M006
Maximum Sterngth Cleansing Pads EquateSALICYLIC ACIDWalmart7db929b6-6470-4840-b016-7e19688548dd2024-03-11WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree OilSALICYLIC ACIDRejoice International7ae434d1-8b07-4121-9163-df07598d41562024-02-28WarningsExact identifier
application number: M006
XtraCare Deep Cleaning AstringentSALICYLIC ACIDRejoice International20cb8584-8a31-40a8-8a47-d9fa8ec8abcf2024-02-28WarningsExact identifier
application number: M006
The INKEY List Beta Hydroxy Acid SerumSALICYLIC ACIDBrand Evangelists for Beauty Ltdd554920f-e33a-484b-bbd8-5137156163842024-02-26WarningsExact identifier
application number: M006
LBRI PURE n NATURAL KlearAwaySALICYLIC ACIDL'BRI Health & Beauty561d17fc-0bbf-4112-9820-7d151cce00982024-02-22WarningsExact identifier
application number: M006
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories5cf3da87-ed50-4791-8f71-1b572f3b8f432024-02-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
application number: M006
Clear Acne Face CleanserACNE FACE CLEANSERKamedis354e2f5b-021b-4683-abe3-7517faf6f7342024-02-07WarningsExact identifier
application number: M006
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
application number: M006
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company0a608bd9-029a-4194-9173-acdcc32056b72024-02-06WarningsExact identifier
application number: M006
CLEAR IMPROVEMENT ACNE CLEARING HYDRATING LTNSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a4bae1-bbbb-0bf3-e063-6294a90a4af62024-02-05WarningsExact 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