FDA.reportPublic FDA data

Maximum Strength Gas Relief

Product NDC
51013-127
Requested package NDC
51013-127-04
11-digit product format
510130127
Labeler code
51013
Product ID
51013-127_934906a6-004b-406c-b560-35672343a86a
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
2016-01-11
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
250 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 packagepackage51013-12751013-127-04IInactivated by FDA2026-10-12

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
51013-127-042025-01-30C16284748780-12cef2736-9c2a-d83d-e063-dadaa90ab31fSIMETHICONE CAPSULES 250 mg, liquid filled
51013-127-222025-01-30C16284748780-12cef2736-9c2a-d83d-e063-dadaa90ab31fSIMETHICONE CAPSULES 250 mg, liquid filled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-127-04Maximum Strength Gas Relief2 in 1 CARTONCAPSULE, LIQUID FILLED22
51013-127-04Maximum Strength Gas Relief12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
51013-127-22Maximum Strength Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED602
51013-127-22Maximum Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51013-127-04EA - Each51013-1276281f552-4558-4876-9102-02d00c07cfa012022-06-06
51013-127-22EA - Each51013-127167f7a65-bd80-462a-b1a4-a5ad99736c5f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-127MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 4 package rows20191221_e36e2db8-c822-4681-a004-c496e8970543.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSNe36e2db8-c822-4681-a004-c496e89705432
412111simethicone 250 MG Oral CapsuleSCDe36e2db8-c822-4681-a004-c496e89705432
412111dimethicone 250 MG Oral CapsuleSYe36e2db8-c822-4681-a004-c496e89705432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-127-04510130127042 BLISTER PACK in 1 CARTON (51013-127-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2016-01-110000-00-00NoNoCurrent