Home NDC 41163-597 Gas Relief
Product NDC 41163-597
11-digit product format 411630597
Labeler code 41163
Product ID 41163-597_b971d55f-ce7b-4ffb-8310-7163c3240b46
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
Substance DIMETHICONE
Active strength 125 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 Gas Relief
Brand name suffix Extra Strength
Listing expiration 2027-12-31 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 198852 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 41163-597-30 Gas ReliefExtra Strength 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 7 41163-597-30 Gas ReliefExtra Strength 30 in 1 CARTON CAPSULE, LIQUID FILLED 30 7 41163-597-50 Gas ReliefExtra Strength 50 in 1 CARTON CAPSULE, LIQUID FILLED 50 7 41163-597-50 Gas ReliefExtra Strength 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-597 GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI] 4 Current NDC, Legacy NDC, 4 package rows 20240615_bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787.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 1 of 13 · 255 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41163-597-30 41163059730 30 BLISTER PACK in 1 CARTON (41163-597-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 30 blister pack 2019-11-29 0000-00-00 No No Current 41163-597-50 41163059750 50 BLISTER PACK in 1 CARTON (41163-597-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 50 blister pack 2019-11-29 0000-00-00 No No Current