FDA.reportPublic FDA data

Extra Strength Gas Relief

Product NDC
21130-317
Requested package NDC
21130-317-50
11-digit product format
211300317
Labeler code
21130
Product ID
21130-317_ef3fe44f-1995-c500-e053-2a95a90a1e39
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Better Living Brands LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-12-22
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-31721130-317-50IInactivated by FDA2026-10-15

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
21130-317-50Extra Strength Gas Relief50 in 1 CARTONCAPSULE, LIQUID FILLED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-317EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [BETTER LIVING BRANDS LLC]5Legacy NDC, 1 package rows20250101_362eaf8b-0aea-4a99-9266-83992bcf444e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN362eaf8b-0aea-4a99-9266-83992bcf444e5
198852simethicone 125 MG Oral CapsuleSCD362eaf8b-0aea-4a99-9266-83992bcf444e5
198852dimethicone 125 MG Oral CapsuleSY362eaf8b-0aea-4a99-9266-83992bcf444e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-317-502113003175050 CAPSULE, LIQUID FILLED in 1 CARTON (21130-317-50) 2021-12-220000-00-00NoNoCurrent