FDA.reportPublic FDA data

Gas relief

Product NDC
63739-225
11-digit product format
637390225
Labeler code
63739
Product ID
63739-225_619f1270-59bb-4214-896c-230bd7f6d6d7
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-10-19
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
80 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-225DDiscontinued by firm2026-10-05
excluded packagepackage63739-22563739-225-02DDiscontinued 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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63739-225DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-22563739-225-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
63739-225-02EA - Each63739-225b1a10cec-24fc-4ab2-b282-7bb3918e6f8112022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSIMETHICONE TABLET [CARDINAL HEALTH]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSIMETHICONE TABLET [CARDINAL HEALTH]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SIMETHICONE TABLET [CARDINAL HEALTH]2
MAGNESIUMINACTIVE INGREDIENTI38ZP9992ASIMETHICONE TABLET [CARDINAL HEALTH]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSIMETHICONE TABLET [CARDINAL HEALTH]2
SORBITOLINACTIVE INGREDIENT506T60A25RSIMETHICONE TABLET [CARDINAL HEALTH]2
STEARYL STEARATEINACTIVE INGREDIENT5WX2EGD0DKSIMETHICONE TABLET [CARDINAL HEALTH]2
SUCROSEINACTIVE INGREDIENTC151H8M554SIMETHICONE TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-225GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON CORPORATION DBA SKY PACKAGING]2Legacy NDC20241220_619f1270-59bb-4214-896c-230bd7f6d6d7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-225-026373902250230 BLISTER PACK in 1 BOX (63739-225-02) > 10 TABLET, CHEWABLE in 1 BLISTER PACK30 blister pack2021-10-190000-00-00NoNoCurrent