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 14 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Ultra Stregth AntacidCALCIUM CARBONATEWal-Mart Stores, Inc.cdfe5c95-3f90-4620-a618-18bac0471c3e2025-12-03WarningsExact identifier
application number: M001
Walgreens Fast Acting Heartburn Relief Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.6eae97f3-a174-4cbc-badc-777475d2f7af2025-11-26WarningsExact identifier
application number: M001
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.2981c5f7-121a-4030-86b1-559061030e7a2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACID CALCIUM CARBONATEWALGREEN CO.14baa410-6ce3-4ddb-aac7-e2172d1506c42025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.aa797e94-6560-41c9-8c71-458a1086e8412025-11-25WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEWALGREEN COMPANYd66ec376-9cac-4de5-aac8-7c6f9aa210ce2025-11-25WarningsExact identifier
application number: M001
Antacid Extra Strength WintergreenANTACIDWALGREEN CO.ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra StrengthANTACIDWALGREEN CO.09ef90c3-1fc3-48be-8071-2fa387a461752025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.6d6cecdc-646b-4c7b-b325-9423c29c57fc2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.e1b55f3a-c6d7-4374-acc7-134786a3765e2025-11-25WarningsExact identifier
application number: M001
ULTRA STRENGTH AntacidCALCIUM CARBONATEWALGREEN COa4dcf7b9-d2c3-45d3-9410-fc4d55052a3c2025-11-25WarningsExact identifier
application number: M001
FAST ACTING Heartburn ReliefALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.48c14005-811a-4868-b33e-9348455048562025-11-25WarningsExact identifier
application number: M001
Walgreens Childrens Saline LaxativeMAGNESIUM HYDROXIDEWALGREEN CO.3813ed22-cf68-4c16-9b61-c398281200792025-11-25WarningsExact identifier
application number: M001
Ultra Strength Assorted BerriesCALCIUM CARBONATESAM'S WEST INCbc619258-7451-460c-9472-95678ea82d6e2025-11-20WarningsExact identifier
application number: M001
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
application number: M001
GERI-MOX ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp03358bc7-8819-4a05-bc13-27fbf486bd262025-11-20WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCd41f0b26-5add-4045-9754-37d70d120d282025-11-20WarningsExact identifier
application number: M001
Tums Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact 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