Home NDC 36800-122 Gas Relief
Product NDC 36800-122
11-digit product format 368000122
Labeler code 36800
Product ID 36800-122_060e2eb9-d8f8-448f-8db4-928ebac288a9
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Topco Associates, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-09-28
Substance DIMETHICONE
Active strength 125 mg/1
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 Gas Relief
Listing expiration 2026-12-31 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 314221 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 36800-122-73 Gas Relief 3 in 1 CARTON TABLET, CHEWABLE 3 2 36800-122-73 Gas Relief 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-122 GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20241228_c90d68a0-22e1-4a37-8487-16ecdc431ede.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 36800-122-73 36800012273 3 BLISTER PACK in 1 CARTON (36800-122-73) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2018-09-28 0000-00-00 No No Current