FDA.reportPublic FDA data

Maximum Strength Gas Relief

Product NDC
68210-4165
11-digit product format
682104165
Labeler code
68210
Product ID
68210-4165_ee8b53d9-2299-e570-e053-2995a90a0f73
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
2021-06-23
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 productproduct68210-4165IInactivated by FDA2026-10-05
excluded packagepackage68210-416568210-4165-7IInactivated 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
68210-4165-7Maximum Strength Gas Relief70 in 1 BOTTLECAPSULE, GELATIN COATED705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4165MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20241215_748638dd-62dc-4e69-a79e-3d4b369ea888.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN748638dd-62dc-4e69-a79e-3d4b369ea8885
412111simethicone 250 MG Oral CapsuleSCD748638dd-62dc-4e69-a79e-3d4b369ea8885
412111dimethicone 250 MG Oral CapsuleSY748638dd-62dc-4e69-a79e-3d4b369ea8885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4165-76821041650770 CAPSULE, GELATIN COATED in 1 BOTTLE (68210-4165-7) 2021-06-230000-00-00NoNoCurrent