Home NDC 41163-096 Infants Gas relief
Product NDC 41163-096
11-digit product format 411630096
Labeler code 41163
Product ID 41163-096_4780240f-e434-439b-bfc2-4d434e9f61c3
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler UNITED NATURAL FOODS, INC. DBA UNFI
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-26
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-096-09 Infants Gas relief 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 2 41163-096-09 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 41163-096 INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC. DBA UNFI] 2 Current NDC, Legacy NDC, 2 package rows 20241222_a9902ba0-f239-4e66-8d66-7cef39a5fdc3.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 41163-096-09 41163009609 1 BOTTLE, DROPPER in 1 CARTON (41163-096-09) / 30 mL in 1 BOTTLE, DROPPER 2021-08-26 0000-00-00 No No Current