FDA.reportPublic FDA data

Gas Relief

Product NDC
36800-125
Requested package NDC
36800-125-50
11-digit product format
368000125
Labeler code
36800
Product ID
36800-125_17e3b2d6-9cf8-469b-981d-ff772d43d3c3
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-10-04
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
180 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 packagepackage36800-12536800-125-50DDiscontinued by firm2026-10-16

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-125-50EA - Each36800-1250863677d-d529-4437-aeca-641d994da63512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2
GELATININACTIVE INGREDIENT2G86QN327LGAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2
WATERINACTIVE INGREDIENT059QF0KO0RGAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-125-50368000125505 BLISTER PACK in 1 CARTON (36800-125-50) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2010-10-040000-00-00NoNoCurrent