Gas relief

Product NDC
41520-550
Requested package NDC
41520-550-30
11-digit product format
415200550
Labeler code
41520
Product ID
41520-550_0045f483-d1fd-4f0d-9642-9411ad8451fd
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-10-27
Marketing end
2022-01-01
Substance
DIMETHICONE
Active strength
125 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage41520-55041520-550-30DDiscontinued by firm2026-10-15

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
GELATININACTIVE INGREDIENT2G86QN327LGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
SORBITOLINACTIVE INGREDIENT506T60A25RGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RGAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-550-30415200550302 BLISTER PACK in 1 CARTON (41520-550-30) > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2010-10-272022-01-01NoNoCurrent