FDA.reportPublic FDA data

Gas Relief

Product NDC
55301-680
11-digit product format
553010680
Labeler code
55301
Product ID
55301-680_d2af1d85-93ce-478a-88f6-39d64a576e38
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-23
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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-680-44Gas ReliefExtra Strength2 in 1 CARTONTABLET, CHEWABLE29
55301-680-44Gas ReliefExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-680GAS RELIEF EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]8Current NDC, Legacy NDC, 2 package rows20240918_b59f4848-1cb1-4061-ac79-fccbe85d1d4c.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 8 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength SimethiconeSIMETHICONEBi-Mart9889575e-6ea3-437a-99e9-f6fe8bcecf252025-04-01WarningsExact identifier
application number: M002
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
application number: M002
Extra Strength Gas Relief Cherry FlavorSIMETHICONEDiscount Drug Mart, Inc2df821f6-e4b5-89ae-e063-6394a90ad4162025-02-24WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEDiscount Drug Mart, Inc2df9117a-97cc-532d-e063-6294a90a1a9c2025-02-20WarningsExact identifier
application number: M002
Alcohol prep padALCOHOL PREP PADTarget Corporationbc9a4f33-3eec-79e3-e053-2a95a90a90172025-02-19WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEBETTER LIVING BRANDS, LLCeb4bef2c-15dd-434a-e053-2a95a90a616f2025-02-12WarningsExact identifier
application number: M002
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c503a99-91da-59f3-e063-6394a90a32ba2025-02-12WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEKROGER COMPANYea1c4aa8-bde6-2072-e053-2995a90a93ba2025-02-10WarningsExact identifier
application number: M002
Gas Relief SIMETHICONE 250 mg Anti-gasSIMETHICONECVS Pharmacy, Inc.63dbc39e-2ba8-4435-9093-d1ad2eb3e8d52025-02-06WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEH E B1894fa42-4aaf-2d17-e063-6394a90a39622025-02-06WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEGuardian Drug Companya5c7c175-1fb7-4b4b-9ba1-b1df1251305c2025-02-06WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEHarris Teeter, LLC2c3a05de-6690-f49a-e063-6394a90a90852025-02-05WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEHarris Teeter, LLC2c39de90-4896-8a85-e063-6394a90af6772025-02-05WarningsExact identifier
application number: M002
Curist Gas Relief Maximum StrengthSIMETHICONELittle Pharma, Inc.dc15a8e6-8924-f5c2-e053-2a95a90ab2c02025-02-04WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEHarris Teeter, LLC2bd9ebda-520c-691a-e063-6294a90af7d32025-02-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff3b61-8a47-14ec-e053-6294a90a2df82025-01-31WarningsExact identifier
application number: M002
Gas relief Anti-gasSIMETHICONECVS2bc548d2-7176-333b-e063-6394a90aae012025-01-29WarningsExact identifier
application number: M002
Ultrastrength Gas ReliefSIMETHICONE SOFT GELATIN CAPSULESCVS PHARMACY, INC24ceba32-eb30-902f-e063-6394a90a9fd52025-01-29WarningsExact identifier
application number: M002
Extra Strength Gas Relief Cherry CremeSIMETHICONECVS2bc522c8-9df0-05b4-e063-6394a90af60c2025-01-27WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSNb59f4848-1cb1-4061-ac79-fccbe85d1d4c9
314221simethicone 125 MG Chewable TabletSCDb59f4848-1cb1-4061-ac79-fccbe85d1d4c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-680-44553010680442 BLISTER PACK in 1 CARTON (55301-680-44) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2021-04-230000-00-00NoNoCurrent