FDA.reportPublic FDA data

Gas Relief

Product NDC
68210-4222
11-digit product format
682104222
Labeler code
68210
Product ID
68210-4222_ed76b037-f2c6-80e7-e053-2995a90a1de5
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
2022-11-14
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 productproduct68210-4222IInactivated by FDA2026-10-23
excluded packagepackage68210-422268210-4222-8IInactivated by FDA2026-10-23

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4222-82026-01-29C16284748780-149896155-ae11-586f-e063-e6dba90add90Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4222-8Gas Relief82 in 1 JARCAPSULE, LIQUID FILLED824

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4222GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_7b055389-c038-400d-8c74-ad8fde701fb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN7b055389-c038-400d-8c74-ad8fde701fb34
198852simethicone 125 MG Oral CapsuleSCD7b055389-c038-400d-8c74-ad8fde701fb34
198852dimethicone 125 MG Oral CapsuleSY7b055389-c038-400d-8c74-ad8fde701fb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4222-86821042220882 CAPSULE, LIQUID FILLED in 1 JAR (68210-4222-8) 2022-11-140000-00-00NoNoCurrent