FDA.reportPublic FDA data

Simethicone

Product NDC
68210-4091
11-digit product format
682104091
Labeler code
68210
Product ID
68210-4091_eec8df20-15c5-8ee3-e053-2995a90ae339
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
2020-07-02
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4091IInactivated by FDA2026-10-12
excluded packagepackage68210-409168210-4091-1IInactivated by FDA2026-10-12

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
68210-4091-1Simethicone75 in 1 BOTTLECAPSULE, LIQUID FILLED757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4091SIMETHICONE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 1 package rows20241213_503b42db-026a-4b0f-90cb-1ea0765c6e84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN503b42db-026a-4b0f-90cb-1ea0765c6e847
198852simethicone 125 MG Oral CapsuleSCD503b42db-026a-4b0f-90cb-1ea0765c6e847
198852dimethicone 125 MG Oral CapsuleSY503b42db-026a-4b0f-90cb-1ea0765c6e847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4091-16821040910175 CAPSULE, LIQUID FILLED in 1 BOTTLE (68210-4091-1) 2020-07-020000-00-00NoNoCurrent