Gas Relief

Product NDC
49035-583
11-digit product format
490350583
Labeler code
49035
Product ID
49035-583_27789231-3930-05a4-e063-6394a90a239b
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-18
Substance
DIMETHICONE
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
Gas Relief
Listing expiration
2026-12-31

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
69351cf9-3092-45ca-8b84-83e3737fa8d4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-583-64Gas Relief150 in 1 BOTTLECAPSULE, LIQUID FILLED1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-583-64EA - Each49035-583ef56571e-a1e1-49a8-9085-e62f88119a8e12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-583GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]2Current NDC, Legacy NDC, 1 package rows20241123_69351cf9-3092-45ca-8b84-83e3737fa8d4.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 7 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.c04422ce-779f-416a-aebf-4ccdfeaaae872025-10-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEHeartland Pharma Co.0860114c-53ec-48bd-a2f2-0b0bf8d2db6e2025-10-03WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEPreferred Pharmaceuticals Inc.544106bc-3c80-4d43-9df3-61a931d1751e2025-09-22WarningsExact identifier
application number: M002
EXTRA STRENGTH SIMETHICONESIMETHICONEBi-Martc1b88a30-ffeb-431c-ab73-728cdc786de02025-09-01WarningsExact identifier
application number: M002
Quality Choice Infants Gas Relief Dye FreeSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)841b85ef-2ac8-4dac-8659-cffb7e1b1e052025-08-23WarningsExact identifier
application number: M002
CVS Health Gas Relief SOFTGELSIMETHICONECVS Pharmacy, Inc2911cac8-45ec-1294-e063-6294a90a4a742025-08-22WarningsExact identifier
application number: M002
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
application number: M002
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
application number: M002
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
application number: M002
Gas-X Ultimate Strength SoftgelsSIMETHICONEHaleon US Holdings LLC24b777e5-f0b5-400d-8ca9-ae0c04b8503b2025-05-20WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
application number: M002
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
application number: M002
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN69351cf9-3092-45ca-8b84-83e3737fa8d42
198852simethicone 125 MG Oral CapsuleSCD69351cf9-3092-45ca-8b84-83e3737fa8d42
198852dimethicone 125 MG Oral CapsuleSY69351cf9-3092-45ca-8b84-83e3737fa8d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-583-6449035058364150 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-583-64) 2017-08-180000-00-00NoNoCurrent