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 19 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC Health Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEMedical Group Care LLC3ea07f5f-59b2-eb0a-e063-6394a90a66b92025-09-12WarningsExact identifier
application number: M001
McKesson Antacid Calcium CarbonateCALCIUM CARBONATEMcKesson Medical-Surgicalbdac6778-384c-50bb-e053-2995a90a0e172025-09-08WarningsExact identifier
application number: M001
Thompson AntacidCALCIUM CARBONATEThompsond9524a64-6f35-24a8-e053-2995a90a6ca32025-09-08WarningsExact identifier
application number: M001
Medique AlcalakCALCIUM CARBONATEUnifirst First Aid Corporation60703e3d-52b1-49c4-b4e2-59d96fa09a782025-09-08WarningsExact identifier
application number: M001
Belmora MELOX AGRURACALCIUM CARBONATEBelmora, LLC875f38f8-4e6f-7517-e053-2995a90a21812025-09-08WarningsExact identifier
application number: M001
Unishield AntacidCALCIUM CARBONATEUnishieldb5e4d635-4c15-a849-e053-2995a90ac5612025-09-08WarningsExact identifier
application number: M001
Green Guard Maximum Strength Stomach ReliefCALCIUM CARBONATE 750 MGUnifirst First Aid Corporation692e09bc-2842-adb9-e053-2991aa0aec492025-09-08WarningsExact identifier
application number: M001
PhysiciansCare AntacidCALCIUM CARBONATEAcme United Corporation0e78664a-ccbb-4b8b-a533-a78d243f8ce82025-09-08WarningsExact identifier
application number: M001
Uline AntacidCALCIUM CARBONATEUline9014f295-e816-9bcd-e053-2a95a90ae1032025-09-08WarningsExact identifier
application number: M001
Medique Ban-acid Maximum Strength 750CALCIUM CARBONATEUnifirst First Aid Corporationa8b70bda-89be-4c1c-998b-3d97ceac9fee2025-09-08WarningsExact identifier
application number: M001
Exchange Select Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de81025-b81c-374a-e063-6394a90a00cf2025-09-03WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 GR (650 MG)SODIUM BICARBONATEAdvanced Rx LLC634e8d52-6d04-42f9-98f6-2634473b5dfd2025-09-01WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEPNP Pharmaceuticals Inc27fde2d4-4d49-d995-e063-6394a90ad6482025-08-31WarningsExact identifier
application number: M001
Exchange Select Calcium Carbonate Antacid Smoothies Extra Strength Assorted BerriesCALCIUM CARBONATEArmy & Air Force Exchange Service3d6fbc95-5f83-a2f5-e063-6394a90a42d52025-08-28WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d4617bb-dfa8-ab8f-e063-6394a90a641b2025-08-26WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC3d465ecd-12cc-ffbd-e063-6394a90aabac2025-08-26WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d46afba-ff44-0088-e063-6294a90a919e2025-08-26WarningsExact identifier
application number: M001
Exchange Select Calcium Carbonate Antacid Smoothies Extra Strength Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d470e3a-3c3f-d2b8-e063-6394a90a7edb2025-08-26WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.f24634a6-bb7e-42e3-a775-723ac030eb1a2025-08-26WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.10d8c5b6-8541-4c82-aa6d-9ae8c624e45e2025-08-26WarningsExact 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