ACNE SOLUTIONS

Product NDC
49527-825
Requested package NDC
49527-825-01
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 packagepackage49527-82549527-825-01DDiscontinued by firm2026-10-20

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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#

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 8 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate BeautySALICYLIC ACIDWALMART INCe4e3226e-61f3-2264-e053-2a95a90a8e782026-05-04WarningsExact identifier
application number: M006
Personal Day Doing the Work Daily Exfoliating TreatmentSALICYLIC ACIDPersonal Day Inc.af9b8b32-b58b-4988-bbf1-2257eaaa9d262026-04-30WarningsExact identifier
application number: M006
Walgreens Pink Grapefruit Acne WashSALICYLIC ACIDWALGREEN COMPANY30cdd09b-10ee-f3a8-e063-6294a90ab77b2026-04-30WarningsExact identifier
application number: M006
Acne DryingSALICYLIC ACIDSpa de Soleilcc0e788a-583c-8414-e053-2995a90a2cb72026-04-30WarningsExact identifier
application number: M006
Acne Treatment PadsSALICYLIC ACIDSpa de Soleilcc0f8f77-1942-22be-e053-2a95a90a3d7f2026-04-30WarningsExact identifier
application number: M006
Zapzyt Acne Treatment GelBENZOYL PEROXIDEFocus Consumer Healthcare, LLC6079d45c-dd86-6f2e-e053-2991aa0a97432026-04-29WarningsExact identifier
application number: M006
PanOxyl Acne Clearing Spot TreatmentBENZOYL PEROXIDECrown Laboratories507150a0-9c20-4a2e-e063-6394a90ab9c72026-04-27WarningsExact identifier
application number: M006
Salicylic Acid 0.5% Body SerumSALICYLIC ACIDDeciem5036dc50-e95c-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M006
Zitsticka Killa Acne Extra StrengthSALICYLIC ACIDBrndxl LLC463db517-be07-8c90-e063-6394a90a4c8c2026-04-22WarningsExact identifier
application number: M006
ZO Skin Health Oil Control Pads Acne TreatmentSALICYLIC ACIDZO Skin Health, Inc.84283a64-8f31-4e98-ad04-948dbe94887d2026-04-22WarningsExact identifier
application number: M006
Tobcharm Acne Treatment Cleansing BarACNE TREATMENT CLEANSING BARGuangzhou Jingliang Cosmetics Co., Ltd.50185cc9-0b3e-64b3-e063-6394a90a0bec2026-04-22WarningsExact identifier
application number: M006
BHA TONERSALICYLIC ACIDDrmtlgy, LLC74010a22-9a3d-4372-9fb3-c660578e675a2026-04-22WarningsExact identifier
application number: M006
Peace Out Acne Care KitSALICYLIC ACIDPeace Out Inc.4ffcd3f9-21a7-465d-e063-6394a90a9a5b2026-04-21WarningsExact identifier
application number: M006
Megababe Chesto Presto Acne MistSALICYLIC ACIDMEGABABE, LLC414cccb5-194d-133c-e063-6394a90a6af02026-04-17WarningsExact identifier
application number: M006
SulfurSoapSULFUR SOAPGuangzhou Bangji International Trade Co., Ltd.4f7f6808-812d-5c4d-e063-6294a90a68d32026-04-15WarningsExact identifier
application number: M006
KEEP IT CLEAR ACNE FOAM CLEANSERKEEP IT CLEAR ACNE FOAM CLEANSERPML NYC, LLCea9442a4-f9f1-4f7c-e053-2a95a90a74432026-04-15WarningsExact identifier
application number: M006
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic AcidSALICYLIC ACIDAnna Lotan Ltd.2b57da0c-889b-41c3-9aca-c60ef49b76032026-04-14WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Prone Skin EssentialsSALICYLIC ACIDKenvue Brands LLC4edc79e7-29a8-5be5-e063-6294a90a62b22026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0b9ebf-e3a7-6fab-e063-6394a90afded2026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bab0a-28cb-effa-e063-6294a90a4be32026-04-09WarningsExact 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
49527-825-01495270825011 TUBE in 1 CARTON (49527-825-01) > 15 mL in 1 TUBE1 tube2022-04-280000-00-00NoNoCurrent