Home NDC 68163-111 Gas Relief
Product NDC 68163-111
11-digit product format 681630111
Labeler code 68163
Product ID 68163-111_3fb19054-20ea-63fb-e063-6394a90aebe5
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Raritan Pharmaceuticals Inc
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-17
Substance DIMETHICONE, UNSPECIFIED
Active strength 80 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
Brand name suffix Mint Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE, UNSPECIFIED 80 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 314216 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 68163-111-36 Gas ReliefMint Flavor 36 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 36 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-111 GAS RELIEF MINT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 1 package rows 20241123_329388cb-3ca1-4ecb-8b50-b1f9e0052559.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 · 256 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68163-111-36 68163011136 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68163-111-36) 2019-04-17 0000-00-00 No No Current