FDA.reportPublic FDA data

ACNE SOLUTIONS

Product NDC
49527-117
11-digit product format
495270117
Labeler code
49527
Product ID
49527-117_3c6a2131-7bad-45ce-e063-6394a90a5eb9
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-21
Substance
BENZOYL PEROXIDE
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-117IInactivated by FDA2026-08-17
excluded packagepackage49527-11749527-117-01IInactivated by FDA2026-08-17
excluded packagepackage49527-11749527-117-02IInactivated by FDA2026-08-17
excluded packagepackage49527-11749527-117-03IInactivated by FDA2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
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#

NDC, Effective, Related label table
NDCEffectiveRelated label
49527-117-012025-08-15ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
49527-117-022025-08-15ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
49527-117-032025-08-15ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
49527-117-012025-07-29ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
49527-117-022025-07-29ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
49527-117-032025-07-29ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-117-01ACNE SOLUTIONSALL-OVER CLEARING TREATMENT50 mL in 1 TUBELOTION503
49527-117-01ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13
49527-117-02ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13
49527-117-02ACNE SOLUTIONSALL-OVER CLEARING TREATMENT30 mL in 1 TUBELOTION303
49527-117-03ACNE SOLUTIONSALL-OVER CLEARING TREATMENT15 mL in 1 TUBELOTION153
49527-117-03ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-117ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT (BENZOYL PEROXIDE) LOTION [CLINIQUE LABORATORIES LLC]2Current NDC, 6 package rows20240723_0d0cfec0-5d18-c347-e063-6394a90a912c.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 1 of 55 · 1,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-08-13WarningsExact identifier
application number: M006
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58d245c3-c685-5784-e063-6294a90a1e232026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.66e0a0a5-22b5-4c89-a949-e996071a585b2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.13b5a729-e265-47fd-b082-2557805d08bc2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.9339d7ed-6e8a-48d2-a5dd-76d395e8d2652026-08-12WarningsExact identifier
application number: M006
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
application number: M006
CLERIVY MICRODART ACNESALICYLIC ACIDGuhada Co., Ltd.555e0963-025e-3731-e063-6394a90a679d2026-08-11WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEMalezia LLCb1304464-bd7e-fb5d-e053-2995a90a54c42026-08-11WarningsExact identifier
application number: M006
SUZANOBAGIMD Acne Cleansing WipesSALICYLIC ACIDObagi Cosmeceuticals LLC91517c5a-1653-41f3-8dfb-a9dea620765c2026-08-10WarningsExact identifier
application number: M006
APUREE Prorevive Maximum Strength AntifungalCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.58860baa-070a-7b73-e063-6294a90acdf02026-08-08WarningsExact identifier
application number: M006
DG Health Athletes FootTOLNAFTATEDolgencorp, LLC42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f2026-08-07WarningsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDCVS Health07cb1c7c-5188-49d5-916e-e2161b5ca3b02026-08-06WarningsExact identifier
application number: M006
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSN0d0cfec0-5d18-c347-e063-6394a90a912c3
200009benzoyl peroxide 25 MG/ML Topical LotionSCD0d0cfec0-5d18-c347-e063-6394a90a912c3
200009benzoyl peroxide 2.5 % Topical LotionSY0d0cfec0-5d18-c347-e063-6394a90a912c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49527-117-01495270117011 TUBE in 1 CARTON (49527-117-01) / 50 mL in 1 TUBE1 tube2023-12-21NoNoHistorical
49527-117-02495270117021 TUBE in 1 CARTON (49527-117-02) / 30 mL in 1 TUBE1 tube2023-12-21NoNoHistorical
49527-117-03495270117031 TUBE in 1 CARTON (49527-117-03) / 15 mL in 1 TUBE1 tube2023-12-21NoNoHistorical