FDA.reportPublic FDA data

Maximum Strength Gas Relief

Product NDC
68210-4223
11-digit product format
682104223
Labeler code
68210
Product ID
68210-4223_ed851b79-b73c-4e6e-e053-2a95a90ae7ac
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
2022-11-15
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 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 productproduct68210-4223IInactivated by FDA2026-10-05
excluded packagepackage68210-422368210-4223-4IInactivated by FDA2026-10-05

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
68210-4223-4Maximum Strength Gas Relief40 in 1 JARCAPSULE, LIQUID FILLED404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4223MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_b514b796-fea5-460c-8b4f-8c6503a41a69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSNb514b796-fea5-460c-8b4f-8c6503a41a694
412111simethicone 250 MG Oral CapsuleSCDb514b796-fea5-460c-8b4f-8c6503a41a694
412111dimethicone 250 MG Oral CapsuleSYb514b796-fea5-460c-8b4f-8c6503a41a694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4223-46821042230440 CAPSULE, LIQUID FILLED in 1 JAR (68210-4223-4) 2022-11-150000-00-00NoNoCurrent