Simethicone

Product NDC
68210-4129
Requested package NDC
68210-4129-1
11-digit product format
682104129
Labeler code
68210
Product ID
68210-4129_ee8bbf84-32bd-6e2b-e053-2a95a90afe08
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-04-27
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-412968210-4129-1IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4129-1Simethicone1 in 1 CARTONCAPSULE, LIQUID FILLED15
68210-4129-1Simethicone15 in 1 BOTTLECAPSULE, LIQUID FILLED155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4129SIMETHICONE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241213_e01b351f-090a-4055-a5f2-55ec32140a30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNe01b351f-090a-4055-a5f2-55ec32140a305
198852simethicone 125 MG Oral CapsuleSCDe01b351f-090a-4055-a5f2-55ec32140a305
198852dimethicone 125 MG Oral CapsuleSYe01b351f-090a-4055-a5f2-55ec32140a305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4129-1682104129011 BOTTLE in 1 CARTON (68210-4129-1) > 15 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-04-270000-00-00NoNoCurrent