FDA.reportPublic FDA data

Gas Relief

Product NDC
51013-115
Requested package NDC
51013-115-01
11-digit product format
510130115
Labeler code
51013
Product ID
51013-115_7b6027bd-a8f8-4872-8dff-2695745f819b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-07-15
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage51013-11551013-115-01IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
51013-115-012025-01-30C16284748780-12cef2736-a838-d83d-e063-dadaa90ab31fGas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-115-01Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
51013-115-01Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-115GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 2 package rows20160715_b2660ac7-a050-459f-a4a0-108e3f994720.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSNb114b07e-6822-465a-9e74-2a741ccb19f77
252294simethicone 180 MG Oral CapsuleSCDb114b07e-6822-465a-9e74-2a741ccb19f77
252294dimethicone 180 MG Oral CapsuleSYb114b07e-6822-465a-9e74-2a741ccb19f77
252294simethicone 180 MG Oral CapsulePSN0add7687-f9d7-4f70-b9a8-1454db8a7caf4
252294simethicone 180 MG Oral CapsulePSNf4526eba-e6d0-44de-99ea-4af7a6dba1994
252294simethicone 180 MG Oral CapsulePSN52cceb6b-f2c8-49bf-b5ce-5d1c999a9b604
252294simethicone 180 MG Oral CapsuleSCD0add7687-f9d7-4f70-b9a8-1454db8a7caf4
252294simethicone 180 MG Oral CapsuleSCDf4526eba-e6d0-44de-99ea-4af7a6dba1994
252294simethicone 180 MG Oral CapsuleSCD52cceb6b-f2c8-49bf-b5ce-5d1c999a9b604
252294dimethicone 180 MG Oral CapsuleSY0add7687-f9d7-4f70-b9a8-1454db8a7caf4
252294dimethicone 180 MG Oral CapsuleSYf4526eba-e6d0-44de-99ea-4af7a6dba1994
252294dimethicone 180 MG Oral CapsuleSY52cceb6b-f2c8-49bf-b5ce-5d1c999a9b604
252294simethicone 180 MG Oral CapsulePSN7ecfe412-6a58-4dff-a52e-2e02a03426f93
252294simethicone 180 MG Oral CapsulePSN33700cc7-48bc-4174-9f9a-36a50b4c91f33
252294simethicone 180 MG Oral CapsulePSN23eda70b-ff1e-4b4e-9f9e-034ef101cd683
252294simethicone 180 MG Oral CapsuleSCD23eda70b-ff1e-4b4e-9f9e-034ef101cd683
252294simethicone 180 MG Oral CapsuleSCD7ecfe412-6a58-4dff-a52e-2e02a03426f93
252294simethicone 180 MG Oral CapsuleSCD33700cc7-48bc-4174-9f9a-36a50b4c91f33
252294dimethicone 180 MG Oral CapsuleSY23eda70b-ff1e-4b4e-9f9e-034ef101cd683
252294dimethicone 180 MG Oral CapsuleSY7ecfe412-6a58-4dff-a52e-2e02a03426f93
252294dimethicone 180 MG Oral CapsuleSY33700cc7-48bc-4174-9f9a-36a50b4c91f33
252294simethicone 180 MG Oral CapsulePSN33bee4db-d4aa-4c72-8eeb-46ff374a92a62
252294simethicone 180 MG Oral CapsuleSCD33bee4db-d4aa-4c72-8eeb-46ff374a92a62
252294dimethicone 180 MG Oral CapsuleSY33bee4db-d4aa-4c72-8eeb-46ff374a92a62
252294simethicone 180 MG Oral CapsulePSNb2660ac7-a050-459f-a4a0-108e3f9947201
252294simethicone 180 MG Oral CapsulePSNcce7f7db-99b8-4d7d-ac77-43da6323ebe11
252294simethicone 180 MG Oral CapsuleSCDcce7f7db-99b8-4d7d-ac77-43da6323ebe11
252294simethicone 180 MG Oral CapsuleSCDb2660ac7-a050-459f-a4a0-108e3f9947201
252294dimethicone 180 MG Oral CapsuleSYb2660ac7-a050-459f-a4a0-108e3f9947201
252294dimethicone 180 MG Oral CapsuleSYcce7f7db-99b8-4d7d-ac77-43da6323ebe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-115-01510130115011 BLISTER PACK in 1 CARTON (51013-115-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2016-07-150000-00-00NoNoCurrent