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 2 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
application number: M002
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
application number: M002
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
application number: M002
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
application number: M002
Tea Tree Oil AntifungalTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.55a48fc6-1963-66ea-e063-6294a90a35012026-07-02WarningsExact identifier
application number: M002
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
application number: M002
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
application number: M002
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
application number: M002
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact 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