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 44 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Moisturizer with Salicylic Acid Acne TreatmentSALICYLIC ACIDTARGET CORPORATION235ca067-e2d4-ca01-e063-6394a90a10502024-09-30WarningsExact identifier
application number: M006
Acne Phage SerumENCAPSULATED SALICYLIC ACIDAllure Labs230d173f-92c1-2e98-e063-6394a90acb212024-09-26WarningsExact identifier
application number: M006
MDacne Customized Acne Treatment SulfurSULFURMDAlgorithms Inc236e7d89-006f-07ac-e063-6394a90ab82b2024-09-26WarningsExact identifier
application number: M006
MDacne Customized Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc236e8d2e-ccd4-0a15-e063-6394a90a73e92024-09-26WarningsExact identifier
application number: M006
Topicals Clearly MistSALICYLIC ACIDTopiderm, Inc.1f1d6751-9566-4738-a28b-f501425b6b212024-09-24WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Daily MoisturizerSALICYLIC ACIDKenvue Brands LLCe426681d-9738-c7ab-e053-2a95a90a9ab32024-09-23WarningsExact identifier
application number: M006
Oxy Maximum Strength Acne Cream CleanserOXY MAXIMUM STRENGTH ACNE CREAM CLEANSERThe Mentholatum Company22ccdcc2-4ee5-2363-e063-6394a90a95942024-09-23WarningsExact identifier
application number: M006
MDacne Customized Acne Treatment Salicylic AcidSALICYLIC ACIDMDAlgorithms Inc3eae8b39-d2c2-4cf7-8c56-7fbaec481fc72024-09-19WarningsExact identifier
application number: M006
MDacne Customized Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inca1f38604-9a42-400d-851e-148d0dc9c86b2024-09-19WarningsExact identifier
application number: M006
MDacne Body Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc97529268-c45c-49c0-8eb0-15c90def69ea2024-09-19WarningsExact identifier
application number: M006
MDacne Customized Acne Cleanser Hydrating Salicylic AcidSALICYLIC ACIDMDAlgorithms Incff01a623-327d-4350-819f-68188c82b9122024-09-19WarningsExact identifier
application number: M006
Aveeno clear complexion daily moisturizerSALICYLIC ACIDKenvue Brands LLCc13dac31-bccb-4fcc-81c4-90e3e63ba59f2024-09-12WarningsExact identifier
application number: M006
MY BEAUTY SPOT Acne Care Patch KitSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.9bec6363-bc71-47fa-8732-33fa7cc58d6c2024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Vitamin ASALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ad7e5be5-7e20-4616-8094-8dae43cfc0052024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ec37a585-3adb-4829-93d1-7814adbdc0962024-09-10WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACID CREAMChina Ningbo Shangge Cosmetics Technology Corp.21cedce7-61e0-6479-e063-6294a90abf5d2024-09-10WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepack4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72024-09-06WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACIDRejoice International Corp.212f77ca-82d3-6a78-e063-6394a90aed322024-09-02WarningsExact identifier
application number: M006
HEALING BLEMISH DOTSSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4e62aee6-978d-4439-83cd-ee24882450e72024-08-28WarningsExact identifier
application number: M006
amazon basics step 3 treatment Acne medicationBENZOYL PEROXIDEAMAZON.COM SERVICES LLCe104ea51-816c-4565-a829-b03957d3d9622024-08-28WarningsExact 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