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 27 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact identifier
application number: M006
Facial Cleansing WipesFACIAL CLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD36f7677a-ec73-e677-e063-6294a90ad4802025-06-07WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
application number: M006
VENROCKSALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.349ae621-c832-128c-e063-6294a90a284d2025-06-05WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONbc9fffbc-c176-4d89-b1c6-294a8439a9302025-06-05WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne AM TreatmentBENZOYL PEROXIDEKenvue Brands LLCd6e05b11-8c5f-490d-a5d8-116dcc895cb82025-06-04WarningsExact identifier
application number: M006
TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADSSALICYLIC ACIDThe Procter & Gamble Manufacturing Company36ada73d-cfc5-d4a4-e063-6294a90a7c732025-06-03WarningsExact identifier
application number: M006
Psoriasis Body WashCOLLOIDAL OATMEALRida LLC4b2bba1b-7e7b-4397-9eb4-d94c44b983142025-06-03WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.4058327e-2764-4df0-9d5d-7cda72d9ca412025-06-02WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd3640d29e-7e4c-b3be-e063-6394a90a0d9e2025-05-29WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC36412939-97bc-6cb1-e063-6294a90aef482025-05-29WarningsExact identifier
application number: M006
Tula Skincare Clear It Up Acne Clearing and Tone Correcting GelSALICYLIC ACIDThe Procter & Gamble Manufacturing Company364a96fb-67fe-eeb7-e063-6394a90aa60c2025-05-29WarningsExact identifier
application number: M006
Psoriasis Scalp TreatmentSALICYLIC ACIDRida LLC14ab77e7-86b0-49d3-8efa-8a80c5a24d742025-05-28WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Foaming CleanserSALICYLIC ACIDKenvue Brands LLCec136786-9d46-a022-e053-2a95a90a07522025-05-26WarningsExact 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