Home NDC 36800-197 Gas Relief
Product NDC 36800-197
11-digit product format 368000197
Labeler code 36800
Product ID 36800-197_19ede766-ef3e-43f1-912b-a6bf2c75ddb5
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
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 36800-197-30 Gas ReliefExtra Strength 30 in 1 CARTON CAPSULE, LIQUID FILLED 30 6 36800-197-30 Gas ReliefExtra Strength 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 6 36800-197-50 Gas ReliefExtra Strength 50 in 1 CARTON CAPSULE, LIQUID FILLED 50 6 36800-197-50 Gas ReliefExtra Strength 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-197 GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] 4 Current NDC, Legacy NDC, 4 package rows 20241115_ed8a723a-7dac-4670-8f02-f4154e0a36c9.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 12 of 13 · 242 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 36800-197-30 36800019730 30 BLISTER PACK in 1 CARTON (36800-197-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 30 blister pack 2019-11-29 0000-00-00 No No Current 36800-197-50 36800019750 50 BLISTER PACK in 1 CARTON (36800-197-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 50 blister pack 2019-11-29 0000-00-00 No No Current