FDA.reportPublic FDA data

Extra Strength Gas Relief

Product NDC
0363-0119
11-digit product format
003630119
Labeler code
0363
Product ID
0363-0119_4469a8dc-7c00-6a5d-e063-6294a90a15c5
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone Antigas
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WALGREENS CO.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-28
Substance
DIMETHICONE, UNSPECIFIED
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
Extra Strength Gas Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0119-18Extra Strength Gas Relief2 in 1 CARTONTABLET, CHEWABLE26
0363-0119-18Extra Strength Gas Relief9 in 1 BLISTER PACKTABLET, CHEWABLE96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0119EXTRA STRENGTH GAS RELIEF (SIMETHICONE ANTIGAS) TABLET, CHEWABLE [WALGREENS CO.]5Current NDC, Legacy NDC, 2 package rows20241110_bf6f5463-a88c-4854-be4d-319582e56479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNbf6f5463-a88c-4854-be4d-319582e564796
314221simethicone 125 MG Chewable TabletSCDbf6f5463-a88c-4854-be4d-319582e564796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0119-18003630119182 BLISTER PACK in 1 CARTON (0363-0119-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2021-01-280000-00-00NoNoCurrent