FDA.reportPublic FDA data

GAS RELIEF

Product NDC
80136-791
Requested package NDC
80136-791-01
11-digit product format
801360791
Labeler code
80136
Product ID
80136-791_ed73e6a3-9ed6-33e4-e053-2995a90a2552
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NORTHEAST PHARMA
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
80 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 packagepackage80136-79180136-791-01IInactivated 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
80136-791-01GAS RELIEF100 in 1 BOTTLETABLET, CHEWABLE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80136-791-01EA - Each80136-7911d9e80f7-e496-4c10-8ab9-f85c88a3fd6812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-791GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [NORTHEAST PHARMA]3Legacy NDC, 1 package rows20231027_d207b006-4f80-3309-e053-2a95a90aaf44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSNd207b006-4f80-3309-e053-2a95a90aaf443
314216simethicone 80 MG Chewable TabletSCDd207b006-4f80-3309-e053-2a95a90aaf443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80136-791-0180136079101100 TABLET, CHEWABLE in 1 BOTTLE (80136-791-01) 2021-06-010000-00-00NoNoCurrent