Antiflatulent

Product NDC
71610-650
11-digit product format
716100650
Labeler code
71610
Product ID
71610-650_2b5b34d8-29c2-fc54-e063-6394a90aaa7a
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-04
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
Antiflatulent
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
71610-650-04Antiflatulent4 in 1 BOTTLETABLET, CHEWABLE44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-650-04EA - Each71610-65039e8a1c8-7af7-48a9-ad0a-a5a24875b17412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-650ANTIFLATULENT (SIMETHICONE) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 1 package rows20250112_dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNdd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea4
314216simethicone 80 MG Chewable TabletSCDdd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-650-04716100650044 TABLET, CHEWABLE in 1 BOTTLE (71610-650-04) 2022-05-190000-00-00NoNoCurrent