Home NDC 35916-1942 Simethicone
Product NDC 35916-1942
11-digit product format 359161942
Labeler code 35916
Product ID 35916-1942_5aa5812e-003c-49b2-e063-6394a90a31b0
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler SOFTGEL HEALTHCARE PRIVATE LIMITED
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-04
Substance DIMETHICONE
Active strength 500 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Simethicone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2477951 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 13 · 255 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35916-1942-1 35916194201 1 BAG in 1 BOX (35916-1942-1) / 1000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2026-09-04 No No Current