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
IngredientStrength
DIMETHICONE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-103-16Gas relief100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-103GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1Current NDC, 1 package rows20250209_a5c7c175-1fb7-4b4b-9ba1-b1df1251305c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNa5c7c175-1fb7-4b4b-9ba1-b1df1251305c1
314216simethicone 80 MG Chewable TabletSCDa5c7c175-1fb7-4b4b-9ba1-b1df1251305c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53041-103-1653041010316100 TABLET, CHEWABLE in 1 BOTTLE (53041-103-16) 2025-02-06NoNoCurrent