FDA.reportPublic FDA data

Extra strength gas relief

Product NDC
41226-722
11-digit product format
412260722
Labeler code
41226
Product ID
41226-722_50970506-5e42-37f7-e063-6294a90a3880
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE
Route
ORAL
Labeler
KROGER COMPANY
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-05
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-722-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-722-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-722-300efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Extra strength gas relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198852Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea1c7b4c-91a1-0c1c-e053-2995a90ab823Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41226-722-302025-02-11C16284748780-12cef2736-a59e-d83d-e063-dadaa90ab31fSimethicone 125 mg soft gelatin capsules
41226-722-302025-01-30C16284748780-12cef2736-a59e-d83d-e063-dadaa90ab31fSimethicone 125 mg soft gelatin capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-722-30Extra strength gas relief2 in 1 CARTONCAPSULE24
41226-722-30Extra strength gas relief15 in 1 BLISTER PACKCAPSULE154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-722EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE [KROGER COMPANY]3Current NDC, 2 package rows20250213_ea1c7b4c-91a1-0c1c-e053-2995a90ab823.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLCef9ecb48-b394-4a85-8ba8-aa397d20cd842026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLC49bd9752-ddfd-4cb1-bef6-22b4e5b95a372026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC1858cf76-cf36-4c56-9e15-14db609aa10f2026-08-07WarningsExact identifier
application number: M001
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
application number: M001
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
application number: M001
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
application number: M001
Best Choice Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)BEST CHOICE (VALU MERCHANDISERS COMPANY)1547b549-efd0-46da-8f91-3d7e4d4a2f3a2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Tropical FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)09e25e8e-a861-45cb-a919-36c30d3b7f7b2026-07-17WarningsExact identifier
application number: M001
LEADER ULTRA STRENGTHANTACID CALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER713c74bf-f586-4c63-82aa-5ed3a611d7a02026-07-17WarningsExact identifier
application number: M001
Best Choice Regular StrengthCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd2026-07-17WarningsExact identifier
application number: M001
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthCALCIUM CARBONATE ,MAGNESIUM HYDROXIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)1989551d-b977-4d5e-8b01-153cd9d638fc2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Assorted BerryCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)412a5be3-2f90-483c-8169-b733861f3aa12026-07-17WarningsExact identifier
application number: M001
Best Choice Assorted FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)cd9e2e11-25a8-4096-870a-9d0269e6c7a92026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthSMOOTH ANTACID TABLETSBEST CHOICE (VALU MERCHANDISERS COMPANY)c5141eb9-d851-453e-b51c-f436a647495a2026-07-17WarningsExact identifier
application number: M001
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
application number: M001
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
application number: M001
Amazon Basics Cherry Antacid SCCALCIUM CARBONATEAmazon4b1d6e4e-8b59-ec06-e063-6394a90aa60d2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNea1c7b4c-91a1-0c1c-e053-2995a90ab8234
198852simethicone 125 MG Oral CapsuleSCDea1c7b4c-91a1-0c1c-e053-2995a90ab8234
198852dimethicone 125 MG Oral CapsuleSYea1c7b4c-91a1-0c1c-e053-2995a90ab8234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-722-30412260722302 BLISTER PACK in 1 CARTON (41226-722-30) / 15 CAPSULE in 1 BLISTER PACK2 blister pack2023-05-05NoNoCurrent