FDA.reportPublic FDA data

LACTO-S

Product NDC
78863-3001
11-digit product format
788633001
Labeler code
78863
Product ID
78863-3001_f2893731-a304-4440-a7ed-264d2fa76c02
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-10
Substance
SALICYLIC ACID
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
LACTO-S
Brand name suffix
ACNE TREATMENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID200 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea0c7fda-30a0-48df-8a1b-4d6098c0081eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-3001-1LACTO-S ACNE TREATMENT1 in 1 CARTONCREAM11
78863-3001-1LACTO-S ACNE TREATMENT15 mL in 1 BOTTLE, PUMPCREAM151
78863-3001-2LACTO-S ACNE TREATMENT1 in 1 CARTONCREAM11
78863-3001-2LACTO-S ACNE TREATMENT50 mL in 1 TUBECREAM501
78863-3001-3LACTO-S ACNE TREATMENT200 mL in 1 BOTTLE, PUMPCREAM2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-3001LACTO-S ACNE TREATMENT (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD]1Current NDC, 5 package rows20250529_ea0c7fda-30a0-48df-8a1b-4d6098c0081e.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 2 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Proactiv 10% BPO WashBENZOYL PEROXIDEAlchemee, LLC58e195bd-f062-00b8-e063-6294a90aee602026-08-10WarningsExact 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
ProBliva Acne Clarifying Body WashSALICYLIC ACID 1%CAVTECH HOLDING LLC57e3989f-f4f5-8b5d-e063-6394a90ac4f32026-07-31WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78863-3001-1788633001011 BOTTLE, PUMP in 1 CARTON (78863-3001-1) / 15 mL in 1 BOTTLE, PUMP2024-06-10NoNoCurrent
78863-3001-2788633001021 TUBE in 1 CARTON (78863-3001-2) / 50 mL in 1 TUBE1 tube2024-06-10NoNoCurrent
78863-3001-378863300103200 mL in 1 BOTTLE, PUMP (78863-3001-3) 200 ml2024-06-10NoNoCurrent