Home NDC 53041-103 Gas relief
Product NDC 53041-103
11-digit product format 530410103
Labeler code 53041
Product ID 53041-103_a5c7c175-1fb7-4b4b-9ba1-b1df1251305c
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Guardian Drug Company
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-06
Substance DIMETHICONE
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 Additional Listing Data#
Finished product Yes
Brand name base Gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 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 53041-103-16 Gas relief 100 in 1 BOTTLE TABLET, CHEWABLE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-103 GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY] 1 Current NDC, 1 package rows 20250209_a5c7c175-1fb7-4b4b-9ba1-b1df1251305c.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 53041-103-16 53041010316 100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16) 2025-02-06 No No Current