FDA.reportPublic FDA data

Simethicone 125 mg

Product NDC
17856-0137
11-digit product format
178560137
Labeler code
17856
Product ID
17856-0137_38930d1f-1f60-1fa5-e063-6394a90a5c21
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0137-12025-04-03C16284748780-11030e364-fccf-111a-e063-dadaa90a10e2Simethicone 125 mg
17856-0137-12024-01-30C16284748780-11030e364-fccf-111a-e063-dadaa90a10e2Simethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0137-1Simethicone 125 mg100 in 1 BOX, UNIT-DOSETABLET, CHEWABLE1004
17856-0137-1Simethicone 125 mg1 in 1 POUCHTABLET, CHEWABLE14
17856-0137-2Simethicone 125 mg1 in 1 POUCHTABLET, CHEWABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0137SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 3 package rows20250406_4ce98db3-c7a6-4627-88c5-9de302a53188.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletSCD4ce98db3-c7a6-4627-88c5-9de302a531884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0137-117856013701100 POUCH in 1 BOX, UNIT-DOSE (17856-0137-1) / 1 TABLET, CHEWABLE in 1 POUCH100 pouch2022-09-290000-00-00NoNoCurrent
17856-0137-2178560137021 TABLET, CHEWABLE in 1 POUCH (17856-0137-2) 2022-09-29NoNoCurrent