FDA.reportPublic FDA data

meijer EXTRA STRENGTH Gas Relief SOFTGEL

Product NDC
79481-0791
11-digit product format
794810791
Labeler code
79481
Product ID
79481-0791_556c1ba6-b957-4a9d-bcab-c797caedd3b4
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Meijer, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-27
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
meijer EXTRA STRENGTH Gas Relief SOFTGEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 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
1befc6cb-a5ad-b950-e063-6394a90a5de3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0791-5meijer EXTRA STRENGTH Gas Relief SOFTGEL25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED252
79481-0791-5meijer EXTRA STRENGTH Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED22
79481-0791-7meijer EXTRA STRENGTH Gas Relief SOFTGEL25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED252
79481-0791-7meijer EXTRA STRENGTH Gas Relief SOFTGEL3 in 1 CARTONCAPSULE, LIQUID FILLED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0791MEIJER EXTRA STRENGTH GAS RELIEF SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [MEIJER, INC.]2Current NDC, 4 package rows20240921_1befc6cb-a5ad-b950-e063-6394a90a5de3.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 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN1befc6cb-a5ad-b950-e063-6394a90a5de32
198852simethicone 125 MG Oral CapsuleSCD1befc6cb-a5ad-b950-e063-6394a90a5de32
198852dimethicone 125 MG Oral CapsuleSY1befc6cb-a5ad-b950-e063-6394a90a5de32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0791-5794810791052 BLISTER PACK in 1 CARTON (79481-0791-5) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2024-06-27NoNoCurrent
79481-0791-7794810791073 BLISTER PACK in 1 CARTON (79481-0791-7) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2024-06-27NoNoCurrent