Home NDC 37835-233 EXTRA STRENGTH SIMETHICONE
Product NDC 37835-233
11-digit product format 378350233
Labeler code 37835
Product ID 37835-233_3f233e89-722c-cc0c-e063-6394a90addde
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bi-Mart
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-01
Substance DIMETHICONE
Active strength 125 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
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 EXTRA STRENGTH SIMETHICONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 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 314221 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37835-233-18 EXTRA STRENGTH SIMETHICONE 2 in 1 CARTON TABLET, CHEWABLE 2 1 37835-233-18 EXTRA STRENGTH SIMETHICONE 9 in 1 BLISTER PACK TABLET, CHEWABLE 9 1
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 · 260 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 37835-233-18 37835023318 2 BLISTER PACK in 1 CARTON (37835-233-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2025-09-01 No No Current