Premier Value

Product NDC
68016-811
11-digit product format
680160811
Labeler code
68016
Product ID
68016-811_a73731e6-56d7-43a9-8623-dc9859be4f38
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PHARMACY VALUE ALLIANCE, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
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
Premier Value
Brand name suffix
Extra Strength
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
68016-811-18Premier ValueExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE96
68016-811-18Premier ValueExtra Strength2 in 1 CARTONTABLET, CHEWABLE26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-811PREMIER VALUE EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_df2b1b62-5bd2-4d02-86c2-537b965a8d20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNdf2b1b62-5bd2-4d02-86c2-537b965a8d206
314221simethicone 125 MG Chewable TabletSCDdf2b1b62-5bd2-4d02-86c2-537b965a8d206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-811-18680160811182 BLISTER PACK in 1 CARTON (68016-811-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-05-150000-00-00NoNoCurrent