FDA.reportPublic FDA data

Gas Relief

Product NDC
59726-897
11-digit product format
597260897
Labeler code
59726
Product ID
59726-897_3213df27-5bfe-444e-babc-46e938a0fb06
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-31
Marketing end
2027-02-01
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
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
Gas Relief
Brand name suffix
Extra Strength

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
4120832d-6c98-43f6-bdac-c88376c88c30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-897-10Gas ReliefExtra Strength10 in 1 CARTONCAPSULE, LIQUID FILLED108
59726-897-10Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
59726-897-15Gas ReliefExtra Strength15 in 1 CARTONCAPSULE, LIQUID FILLED158
59726-897-15Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
59726-897-20Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
59726-897-20Gas ReliefExtra Strength20 in 1 CARTONCAPSULE, LIQUID FILLED208
59726-897-30Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
59726-897-30Gas ReliefExtra Strength30 in 1 CARTONCAPSULE, LIQUID FILLED308
59726-897-50Gas ReliefExtra Strength50 in 1 CARTONCAPSULE, LIQUID FILLED508
59726-897-50Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
59726-897-51Gas ReliefExtra Strength150 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-897GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 11 package rows20240501_4120832d-6c98-43f6-bdac-c88376c88c30.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 12 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Ultra StrengthSIMETHICONEH E Bd83f2dcf-c8c6-4581-9406-6bad8d39d03e2024-04-09WarningsExact identifier
application number: M002
Gas-X Ultra Strength AntiGas SoftgelsSIMETHICONEHaleon US Holdings LLCee9a8404-0653-433f-90e5-7ac69bdab8df2024-04-05WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONECVS Pharmacybac06147-87ae-4aaa-a66b-4aeae6096d8d2024-03-13WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEWALGREENS03bc9c99-2871-2604-e063-6394a90a2be52024-03-06WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
application number: M002
Anti-Gas Ultra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)f74d9882-cc99-41b6-b851-ce89d28f33df2024-02-15WarningsExact identifier
application number: M002
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
application number: M002
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
application number: M002
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief OriginalSIMETHICONEInfirst Healthcare395be942-d883-4bcb-8811-6fe1521d5a922024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
application number: M002
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
application number: M002
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
application number: M002
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
application number: M002
GAS RELIEFSIMETHICONESTRATEGIC SOURCING SERVICES LLCff1fd97c-af4f-dffb-e053-6294a90a20392023-10-26WarningsExact identifier
application number: M002
INFANT GAS RELIEFSIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION7d3c3cc6-b0a2-620d-e053-2a91aa0a159b2023-07-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN4120832d-6c98-43f6-bdac-c88376c88c308
198852simethicone 125 MG Oral CapsuleSCD4120832d-6c98-43f6-bdac-c88376c88c308
198852dimethicone 125 MG Oral CapsuleSY4120832d-6c98-43f6-bdac-c88376c88c308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-897-105972608971010 BLISTER PACK in 1 CARTON (59726-897-10) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2019-07-312027-02-01NoNoCurrent
59726-897-155972608971515 BLISTER PACK in 1 CARTON (59726-897-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK15 blister pack2019-07-312027-02-01NoNoCurrent
59726-897-205972608972020 BLISTER PACK in 1 CARTON (59726-897-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK20 blister pack2019-07-312027-02-01NoNoHistorical
59726-897-305972608973030 BLISTER PACK in 1 CARTON (59726-897-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2019-07-312027-02-01NoNoCurrent
59726-897-505972608975050 BLISTER PACK in 1 CARTON (59726-897-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2019-07-312027-02-01NoNoCurrent
59726-897-5159726089751150 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59726-897-51) 2019-07-312027-02-01NoNoCurrent