FDA.reportPublic FDA data

Gas Relief

Product NDC
72090-014
11-digit product format
720900014
Labeler code
72090
Product ID
72090-014_28f774fb-6c16-4668-9edb-b683fed8e88f
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone 125 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-19
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
Listing expiration
2027-12-31

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
2c7bac92-4596-40aa-a2f2-4ebe380f1f2fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-014-01Gas Relief180 in 1 BOTTLECAPSULE, LIQUID FILLED1801

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
198852simethicone 125 MG Oral CapsulePSN2c7bac92-4596-40aa-a2f2-4ebe380f1f2f1
198852simethicone 125 MG Oral CapsuleSCD2c7bac92-4596-40aa-a2f2-4ebe380f1f2f1
198852dimethicone 125 MG Oral CapsuleSY2c7bac92-4596-40aa-a2f2-4ebe380f1f2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72090-014-0172090001401180 CAPSULE, LIQUID FILLED in 1 BOTTLE (72090-014-01) 2025-11-19NoNoCurrent