Home NDC 78863-3001 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 Ingredient Strength SALICYLIC ACID 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78863-3001-1 LACTO-S ACNE TREATMENT 1 in 1 CARTON CREAM 1 1 78863-3001-1 LACTO-S ACNE TREATMENT 15 mL in 1 BOTTLE, PUMP CREAM 15 1 78863-3001-2 LACTO-S ACNE TREATMENT 1 in 1 CARTON CREAM 1 1 78863-3001-2 LACTO-S ACNE TREATMENT 50 mL in 1 TUBE CREAM 50 1 78863-3001-3 LACTO-S ACNE TREATMENT 200 mL in 1 BOTTLE, PUMP CREAM 200 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78863-3001 LACTO-S ACNE TREATMENT (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD] 1 Current NDC, 5 package rows 20250529_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 7 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78863-3001-1 78863300101 1 BOTTLE, PUMP in 1 CARTON (78863-3001-1) / 15 mL in 1 BOTTLE, PUMP 2024-06-10 No No Current 78863-3001-2 78863300102 1 TUBE in 1 CARTON (78863-3001-2) / 50 mL in 1 TUBE 1 tube 2024-06-10 No No Current 78863-3001-3 78863300103 200 mL in 1 BOTTLE, PUMP (78863-3001-3) 200 ml 2024-06-10 No No Current