Home NDC 35916-1940 Simethicone
Product NDC 35916-1940
11-digit product format 359161940
Labeler code 35916
Product ID 35916-1940_5d4f8288-434e-27f8-e063-6394a90a416d
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 2025-10-28
Substance DIMETHICONE
Active strength 250 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 250 mg/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-1940-1 Simethicone 1000 in 1 BAG CAPSULE, LIQUID FILLED 1000 3 35916-1940-2 Simethicone 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 3 35916-1940-2 Simethicone 5 in 1 CARTON CAPSULE, LIQUID FILLED 5 3
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 5 of 13 · 242 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 35916-1940-1 35916194001 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1) 2025-10-28 No No Current 35916-1940-2 35916194002 5 BLISTER PACK in 1 CARTON (35916-1940-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 5 blister pack 2025-10-28 No No Current