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 13 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Extra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.51759451-63a8-0fb4-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.84771ac5-ad0b-e0ec-e053-2a91aa0a1b362025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.bdb43d3b-ddcd-4359-a174-a5556e7c5f572025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChewsCALCIUM CARBONATEBayer HealthCare LLC.7857c357-38cb-2f61-e053-2991aa0a66022025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M001
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
application number: M001
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
application number: M001
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
application number: M001
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
application number: M001
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
application number: M001
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
application number: M001
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
application number: M001
Quality Choice Ultra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION63318b46-d47d-474c-8fb5-5e0d53b7adb42025-12-03WarningsExact identifier
application number: M001
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.8064b01a-e049-4d49-a5b6-e72dbeb5daac2025-12-03WarningsExact identifier
application number: M001
calcium antacidextra strength extra strengthCALCIUM CARBONATERugby Laboratoriesd761954f-940e-4833-87b7-173a921aade12025-12-03WarningsExact 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