Simethicone 125 mg

Product NDC
69618-032
11-digit product format
696180032
Labeler code
69618
Product ID
69618-032_2bc80ff5-2de5-ff04-e063-6294a90a5026
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Reliable 1 Laboratires LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-25
Substance
DIMETHICONE
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
Simethicone 125 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-032-062023-03-29C16284748780-1f386c649-d93c-0266-e053-dadaa90a7c1aSimethicone 125 mg
69618-032-062023-01-30C16284748780-1f386c649-d93c-0266-e053-dadaa90a7c1aSimethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-032-06Simethicone 125 mg60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-032SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATIRES LLC]9Current NDC, Legacy NDC, 1 package rows20250117_330aed4b-7109-09b8-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN330aed4b-7109-09b8-e054-00144ff8d46c9
314221simethicone 125 MG Chewable TabletSCD330aed4b-7109-09b8-e054-00144ff8d46c9
314221simethicone 125 MG Chewable TabletPSN4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletSCD4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletPSN078ef54e-96b2-4e2f-bebc-9b9bcda1f90a1
314221simethicone 125 MG Chewable TabletSCD078ef54e-96b2-4e2f-bebc-9b9bcda1f90a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-032-066961800320660 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-032-06) 2018-04-250000-00-00NoNoCurrent