Home NDC 71444-788 simethicone gas relief
Product NDC 71444-788
11-digit product format 714440788
Labeler code 71444
Product ID 71444-788_15ad0793-046c-49ff-e063-6394a90a301b
Type HUMAN OTC DRUG
Nonproprietary name simethicone
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler MOM Enterprises, LCC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-08-01
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 simethicone 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198857 Internal RxNorm 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 71444-788-01 simethicone gas relief 30 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 30 7 71444-788-01 simethicone gas relief 1 in 1 CARTON SUSPENSION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71444-788 SIMETHICONE GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [MOM ENTERPRISES, LCC] 7 Current NDC, 2 package rows 20240410_536ecfdf-7124-502a-e054-00144ff8d46c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71444-788-01 71444078801 1 BOTTLE, DROPPER in 1 CARTON (71444-788-01) / 30 mL in 1 BOTTLE, DROPPER 2017-08-01 No No Current