FDA.reportPublic FDA data

GAS RELIEF

Product NDC
57896-799
Requested package NDC
57896-799-01
11-digit product format
578960799
Labeler code
57896
Product ID
57896-799_eeb4aa2a-9308-2b11-e053-2995a90a3581
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-01
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 packagepackage57896-79957896-799-01DDiscontinued by firm2026-10-05

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-79957896-799-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-79957896-799-01IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-79957896-799-01IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57896-799-012022-12-15gc 791a (799)
57896-799-082022-12-15gc 791a (799)
57896-799-012022-01-28gc 791a (799)
57896-799-082022-01-28gc 791a (799)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-799-01EA - Each57896-799a4b10310-54df-455c-a2da-6bb896ac436c12021-03-02
57896-799-08EA - Each57896-799a719d384-226d-4303-9d1b-b9b42aa318d812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-799GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]3Legacy NDC20231027_b66f63d0-be82-a75b-e053-2a95a90a3f13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-799-0157896079901100 TABLET, CHEWABLE in 1 BOTTLE (57896-799-01) 2020-02-010000-00-00NoNoCurrent