Home NDC 84324-014 Gas Relief Simethicone 125mg Softgel
Product NDC 84324-014
11-digit product format 843240014
Labeler code 84324
Product ID 84324-014_5b5f1c15-7b17-42be-b068-804e60596153
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NUVICARE LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-18
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 Additional Listing Data#
Finished product Yes
Brand name base Gas Relief Simethicone 125mg Softgel
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 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 84324-014-01 Gas Relief Simethicone 125mg Softgel 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84324-014 GAS RELIEF SIMETHICONE 125MG SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [NUVICARE LLC] 1 Current NDC, 1 package rows 20240719_b774c8e6-e68e-4a13-834d-7eba34c5c3e0.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 · 258 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84324-014-01 84324001401 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01) 2024-07-18 No No Current