TopCare Extra Strength Gas Relief

Product NDC
36800-488
11-digit product format
368000488
Labeler code
36800
Product ID
36800-488_433a62cb-23ea-bbb3-e063-6294a90ac883
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-07
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
TopCare Extra Strength Gas Relief
Brand name suffix
Cherry Creme
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
36800-488-48TopCare Extra Strength Gas ReliefCherry Creme48 in 1 BOTTLE, PLASTICTABLET, CHEWABLE487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-488TOPCARE EXTRA STRENGTH GAS RELIEF CHERRY CREME (SIMETHICONE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241107_4d1701fd-b797-4e95-9004-84d528941e72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN4d1701fd-b797-4e95-9004-84d528941e727
314221simethicone 125 MG Chewable TabletSCD4d1701fd-b797-4e95-9004-84d528941e727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-488-483680004884848 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (36800-488-48) 2019-03-070000-00-00NoNoCurrent