SIMETHICONE

Product NDC
68071-2746
11-digit product format
680712746
Labeler code
68071
Product ID
68071-2746_2eeb54a1-cc84-0293-e063-6294a90a8f00
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2746-32025-02-25C16284748780-12cef2736-97c3-d83d-e063-dadaa90ab31fgc 791
68071-2746-32025-01-30C16284748780-12cef2736-97c3-d83d-e063-dadaa90ab31fgc 791

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2746-3SIMETHICONE30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2746SIMETHICONE TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250227_e07f6acc-1b75-d8eb-e053-2a95a90a7d9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNe07f6acc-1b75-d8eb-e053-2a95a90a7d9b2
314216simethicone 80 MG Chewable TabletSCDe07f6acc-1b75-d8eb-e053-2a95a90a7d9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2746-36807127460330 TABLET, CHEWABLE in 1 BOTTLE (68071-2746-3) 2022-06-020000-00-00NoNoCurrent