Home NDC 36800-119 Infants Gas relief
Product NDC 36800-119
11-digit product format 368000119
Labeler code 36800
Product ID 36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4a
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Topco Associates, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-03-01
Substance DIMETHICONE
Active strength 20 mg/.3mL
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 Infants Gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
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 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 36800-119-09 Infants Gas relief 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 2 36800-119-09 Infants Gas relief 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-119 INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [TOPCO ASSOCIATES, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20241228_fd6a2537-8db2-492d-b045-6404df2fb9c3.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 5 of 13 · 242 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-119-09 36800011909 1 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER 2013-03-01 0000-00-00 No No Current