FDA.reportPublic FDA data

Simethicone

Product NDC
68210-4154
Requested package NDC
68210-4154-2
11-digit product format
682104154
Labeler code
68210
Product ID
68210-4154_ee8ee49e-5b66-ed5a-e053-2a95a90a5840
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-04-29
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
180 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 packagepackage68210-415468210-4154-2IInactivated by FDA2026-09-14

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
68210-4154-2Simethicone10 in 1 BLISTER PACKCAPSULE, GELATIN COATED105
68210-4154-2Simethicone2 in 1 CARTONCAPSULE, GELATIN COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4154SIMETHICONE CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241213_28cd4c11-6ce2-4cb8-b916-d6528fb63fa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN28cd4c11-6ce2-4cb8-b916-d6528fb63fa95
252294simethicone 180 MG Oral CapsuleSCD28cd4c11-6ce2-4cb8-b916-d6528fb63fa95
252294dimethicone 180 MG Oral CapsuleSY28cd4c11-6ce2-4cb8-b916-d6528fb63fa95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4154-2682104154022 BLISTER PACK in 1 CARTON (68210-4154-2) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK2 blister pack2021-04-290000-00-00NoNoCurrent