FDA.reportPublic FDA data

Gas Relief Ultra Strength

Product NDC
53345-003
11-digit product format
533450003
Labeler code
53345
Product ID
53345-003_2752c444-2bca-7d23-e063-6394a90a9c67
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone 180 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-15
Substance
DIMETHICONE 410
Active strength
180 mg/1
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
Gas Relief Ultra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE 410180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TYU5GP6XGEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252294Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cfb8132-6de4-457d-880b-c870a38862adAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-003-03Gas Relief Ultra Strength1 in 1 BOXCAPSULE, LIQUID FILLED13
53345-003-03Gas Relief Ultra Strength25000 in 1 BAGCAPSULE, LIQUID FILLED250003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONE 410ACTIVE INGREDIENTTYU5GP6XGEGAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
DIMETHICONE 410ACTIVE MOIETYTYU5GP6XGEGAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GELATININACTIVE INGREDIENT2G86QN327LGAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RGAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-003GAS RELIEF ULTRA STRENGTH (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]3Current NDC, Legacy NDC, 2 package rows20241123_2cfb8132-6de4-457d-880b-c870a38862ad.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 6 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEMeijer Distribution, Inc.7723821e-b2fc-4c9c-a389-05184aaea19f2025-11-15WarningsExact identifier
application number: M002
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
application number: M002
up and up extra strength gas relief chewables Extra StrengthSIMETHICONETarget Corporation0a015c48-680c-4de1-91e7-1c1145239d8e2025-11-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
application number: M002
PUBLIX Extra StrengthSIMETHICONEPUBLIX SUPER MARKETS, INC089d77c9-7aa0-4eee-8363-c47a2d5928cf2025-10-28WarningsExact identifier
application number: M002
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
application number: M002
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
application number: M002
Infants Gas Relief DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
application number: M002
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
application number: M002
Meijer Extra Strength Gas ReliefSIMETHICONEMEIJER DISTRIBUTION INC1e8dc937-ad86-4560-bcc1-3f23fbfe8c642025-10-24WarningsExact identifier
application number: M002
Meijer Infants Gas Relief DropsSIMETHICONEMEIJER DISTRIBUTION INC.4493efcd-a547-4700-9e6a-a67d6420edb52025-10-24WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN2cfb8132-6de4-457d-880b-c870a38862ad3
252294simethicone 180 MG Oral CapsuleSCD2cfb8132-6de4-457d-880b-c870a38862ad3
252294dimethicone 180 MG Oral CapsuleSY2cfb8132-6de4-457d-880b-c870a38862ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-003-03533450003031 BAG in 1 BOX (53345-003-03) / 25000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-04-150000-00-00NoNoCurrent