FDA.reportPublic FDA data

ACNE solutions CLARIFYING

Product NDC
49527-723
11-digit product format
495270723
Labeler code
49527
Product ID
49527-723_273cd5d9-b149-5eb9-e063-6394a90a58a0
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-09-01
Substance
SALICYLIC ACID
Active strength
15 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct49527-723EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49527-72349527-723-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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 CLARIFYING
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID15 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
422997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc1b2e2e-0e13-4029-bdac-44adb70492fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-05ACNE SOLUTIONS CLARIFYING LOTION
2022-07-29ACNE SOLUTIONS CLARIFYING LOTION
2020-03-19ACNE SOLUTIONS CLARIFYING LOTION
2020-01-31ACNE SOLUTIONS CLARIFYING LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-723-01ACNE solutions CLARIFYING200 mL in 1 BOTTLE, PLASTICLIQUID20012
49527-723-02ACNE solutions CLARIFYING1 in 1 CARTONLIQUID112
49527-723-02ACNE solutions CLARIFYING60 mL in 1 BOTTLELIQUID6012
49527-723-03ACNE solutions CLARIFYING100 mL in 1 BOTTLELIQUID10012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
10-HYDROXYDECANOIC ACIDINACTIVE INGREDIENTNP03XO416BACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2EACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
CAFFEINEINACTIVE INGREDIENT3G6A5W338EACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKINACTIVE INGREDIENTT7S323PKJSACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
N-ACETYLGLUCOSAMINEINACTIVE INGREDIENTV956696549ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
NYLON-12INACTIVE INGREDIENT446U8J075BACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX5ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
SACCHARINA LATISSIMA THALLUSINACTIVE INGREDIENT68CMP2MB55ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-723ACNE SOLUTIONS CLARIFYING (SALICYLIC ACID) LIQUID [CLINIQUE LABORATORIES LLC]12Current NDC, Legacy NDC, 4 package rows20241120_dc1b2e2e-0e13-4029-bdac-44adb70492fd.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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony 10% SulfurSULFURD3 Development, Inc.c78ead80-a8ee-0b52-e053-2a95a90ab8802025-12-01WarningsExact identifier
application number: M006
Dermaharmony 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDOars And Alps LLCefe14f46-c947-aea4-e053-2a95a90aad5f2025-12-01WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422997salicylic acid 1.5 % Topical LotionPSNdc1b2e2e-0e13-4029-bdac-44adb70492fd12
422997salicylic acid 15 MG/ML Topical LotionSCDdc1b2e2e-0e13-4029-bdac-44adb70492fd12
422997salicylic acid 1.5 % Topical LotionSYdc1b2e2e-0e13-4029-bdac-44adb70492fd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-723-0149527072301200 mL in 1 BOTTLE, PLASTIC (49527-723-01) 200 ml2006-09-010000-00-00NoNoCurrent
49527-723-02495270723021 BOTTLE in 1 CARTON (49527-723-02) / 60 mL in 1 BOTTLE1 bottle2022-03-020000-00-00NoNoCurrent
49527-723-0349527072303100 mL in 1 BOTTLE (49527-723-03) 100 ml2023-10-20NoNoCurrent