Simethicone

Product NDC
71610-607
11-digit product format
716100607
Labeler code
71610
Product ID
71610-607_2b4cfbd3-496e-100d-e063-6294a90aba52
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
2011-03-01
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
Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314216

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-607-04Simethicone4 in 1 BOTTLETABLET, CHEWABLE43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-607-04EA - Each71610-607f832fb39-307f-4d6a-a612-8a63bf7ec35812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-607SIMETHICONE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 1 package rows20250112_da0cc98e-1692-405a-ab81-420d6f9df6de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNda0cc98e-1692-405a-ab81-420d6f9df6de3
314216simethicone 80 MG Chewable TabletSCDda0cc98e-1692-405a-ab81-420d6f9df6de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-607-04716100607044 TABLET, CHEWABLE in 1 BOTTLE (71610-607-04) 2021-10-250000-00-00NoNoCurrent