FDA.reportPublic FDA data

ACNE SOLUTIONS

Product NDC
49527-825
Requested package NDC
49527-825-03
11-digit product format
495270825
Labeler code
49527
Product ID
49527-825_4bbc494e-e1c7-7800-e063-6294a90a9f64
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-01
Marketing end
2027-04-19
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49527-82549527-825-03DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ACNE SOLUTIONS
Brand name suffix
SPOT HEALING ACNE MEDICATION

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251380Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c09ee4f6-b8f9-4d20-982a-fb490830bd34Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-825-012021-04-13C16284748780-19d75b9d0-dac8-f424-e053-dadaa90a57ceACNE SOLUTIONS SPOT HEALING ACNE MEDICATION
49527-825-012020-01-31C16284748780-19d75b9d0-dac8-f424-e053-dadaa90a57ceACNE SOLUTIONS SPOT HEALING ACNE MEDICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-825-01ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION15 mL in 1 TUBEGEL1511
49527-825-01ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-02ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-02ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION30 mL in 1 BOTTLEGEL3011
49527-825-03ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-03ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION3 mL in 1 TUBEGEL311
49527-825-04ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1.5 mL in 1 PACKETGEL1.511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX5ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
WATERINACTIVE INGREDIENT059QF0KO0RACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2
WITCH HAZELINACTIVE INGREDIENT101I4J0U34ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES INC]2

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 1 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
application number: M006
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
application number: M006
Abib Acne foam cleanser Heartleaf foamSALICYLIC ACIDFourcompany Co., Ltd.5aa353ad-0ca5-77c1-e063-6394a90a62542026-09-04WarningsExact identifier
application number: M006
Dr.Leo Acne Buster Salicylic Acid DryingSALICYLIC ACIDDoctor Leo USA Inc5792fa71-eb6b-3c70-e063-6394a90abde82026-09-03WarningsExact identifier
application number: M006
Blackhead Clearing ScrugSALICYLIC ACIDWalmart Inc.6989591a-a78b-4971-baf2-51ebfaf9c7e72026-09-02Warnings, Adverse reactionsExact identifier
application number: M006
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
application number: M006
Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.5a93f753-eb7d-ad11-e063-6294a90a67782026-09-01WarningsExact identifier
application number: M006
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
application number: M006
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
application number: M006
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
application number: M006
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
application number: M006
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
application number: M006
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
application number: M006
Acne Treatment CreamBENZOYL PEROXIDECVS Healthaef82711-e3c3-439d-adda-542933ff44202026-08-19WarningsExact identifier
application number: M006
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 2% MILIA REMOVERShenzhen Jindali Technology Co., Ltd596a2471-d07c-14a5-e063-6394a90a4fcc2026-08-19WarningsExact identifier
application number: M006
RFA Clear and Calm Balancing SerumSALICYLIC ACIDTopiderm, Inc.f63f2c89-3567-4b08-be51-3fdfc5e0b1ba2026-08-14WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSNc09ee4f6-b8f9-4d20-982a-fb490830bd3411
251380salicylic acid 0.01 MG/MG Topical GelSCDc09ee4f6-b8f9-4d20-982a-fb490830bd3411
251380salicylic acid 1 % Topical GelSYc09ee4f6-b8f9-4d20-982a-fb490830bd3411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-825-03495270825031 TUBE in 1 CARTON (49527-825-03) > 3 mL in 1 TUBE1 tube2022-04-280000-00-00NoNoCurrent