FDA.reportPublic FDA data

Gas Relief

Product NDC
0363-8970
11-digit product format
003638970
Labeler code
0363
Product ID
0363-8970_02fc412a-dcca-43e3-936b-aff7b6c5c7eb
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
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

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
afcabb34-4ef4-4938-860f-154c204fcd48Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8970-20Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
0363-8970-20Gas ReliefExtra Strength20 in 1 CARTONCAPSULE, LIQUID FILLED208
0363-8970-50Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
0363-8970-50Gas ReliefExtra Strength50 in 1 CARTONCAPSULE, LIQUID FILLED508
0363-8970-72Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED18
0363-8970-72Gas ReliefExtra Strength72 in 1 CARTONCAPSULE, LIQUID FILLED728

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8970GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [WALGREENS]5Current NDC, Legacy NDC, 6 package rows20240627_afcabb34-4ef4-4938-860f-154c204fcd48.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 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
HEB Gas Relief Extra Strength PeppermintSIMETHICONEH E B52f6db66-ce4c-40dc-b483-6ba83977cd8b2025-01-20WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEReliable 1 Laboratires LLC330aed4b-7109-09b8-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M002
Simethicone 80 mgSIMETHICONEReliable 1 Laboratories LLC32fb242b-7051-072c-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEAphena Pharma Solutions - Tennessee, LLC5df94be7-0bc9-4be1-9982-8193e3a3c8ef2025-01-10WarningsExact identifier
application number: M002
AntiflatulentSIMETHICONEAphena Pharma Solutions - Tennessee, LLCdd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea2025-01-10WarningsExact identifier
application number: M002
Anti-Gas StripSIMETHICONECalmourc1576ee9-69ff-41ff-b2d0-7703c8fa8edd2025-01-09WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEAMZ789 LLCbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa22025-01-08WarningsExact identifier
application number: M002
Simethicone 250mgSIMETHICONE 250MGAMZ789 LLCfcc2ef8b-9181-2c59-e053-6394a90adcc12025-01-08WarningsExact identifier
application number: M002
extra strength Gas Relief cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC5dcd50ae-370d-4e49-b981-db42b86c2ecb2025-01-01WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONETopco Associates, LLCc90d68a0-22e1-4a37-8487-16ecdc431ede2024-12-26WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNafcabb34-4ef4-4938-860f-154c204fcd488
198852simethicone 125 MG Oral CapsuleSCDafcabb34-4ef4-4938-860f-154c204fcd488
198852dimethicone 125 MG Oral CapsuleSYafcabb34-4ef4-4938-860f-154c204fcd488

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8970-200036389702020 BLISTER PACK in 1 CARTON (0363-8970-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK20 blister pack2019-11-290000-00-00NoNoCurrent
0363-8970-500036389705050 BLISTER PACK in 1 CARTON (0363-8970-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2019-11-290000-00-00NoNoCurrent
0363-8970-720036389707272 BLISTER PACK in 1 CARTON (0363-8970-72) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK72 blister pack2019-11-290000-00-00NoNoCurrent