Gas Relief

Product NDC
55319-487
11-digit product format
553190487
Labeler code
55319
Product ID
55319-487_5b1f1c71-5a06-4ac1-97ed-baa62e30e487
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-02-29
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
125 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-487DDiscontinued by firm2026-10-12
excluded packagepackage55319-48755319-487-30DDiscontinued by firm2026-10-12
excluded packagepackage55319-48755319-487-50DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-487-50DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-487-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-487-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-487-50IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-487-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-487-50IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-487-30IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-487-50IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55319-487-302023-01-25Drug Facts
55319-487-502023-01-25Drug Facts
55319-487-302022-01-28Drug Facts
55319-487-502022-01-28Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-487GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]6Legacy NDC20230126_45e5a1bb-bd75-4c0f-8c7b-ef13fc49acfa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-487-305531904873030 BLISTER PACK in 1 CARTON (55319-487-30) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2016-02-290000-00-00NoNoCurrent
55319-487-505531904875050 BLISTER PACK in 1 CARTON (55319-487-50) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2016-02-290000-00-00NoNoCurrent