FDA.reportPublic FDA data

gas relief

Product NDC
49348-863
11-digit product format
493480863
Labeler code
49348
Product ID
49348-863_49a1150d-e7cb-4de1-92c4-fb4c713f9676
Type
HUMAN OTC DRUG
Nonproprietary name
simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
125 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-863DDiscontinued by firm2026-08-17
excluded packagepackage49348-86349348-863-48DDiscontinued by firm2026-08-17

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 productproduct49348-863DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-86349348-863-48DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-863-48EA - Each49348-86328cedf92-b656-4387-9a65-9c10b0bb03e912013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
SORBITOLINACTIVE INGREDIENT506T60A25RGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1
SUCROSEINACTIVE INGREDIENTC151H8M554GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-863GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC20241222_7c67c004-748b-4892-8b15-0a7d68108488.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-863-48493480863482 BLISTER PACK in 1 CARTON (49348-863-48) > 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-09-180000-00-00NoNoCurrent