FDA.reportPublic FDA data

Gas Relief

Product NDC
41163-597
11-digit product format
411630597
Labeler code
41163
Product ID
41163-597_b971d55f-ce7b-4ffb-8310-7163c3240b46
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
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
bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-597-30Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17
41163-597-30Gas ReliefExtra Strength30 in 1 CARTONCAPSULE, LIQUID FILLED307
41163-597-50Gas ReliefExtra Strength50 in 1 CARTONCAPSULE, LIQUID FILLED507
41163-597-50Gas ReliefExtra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-597-30EA - Each41163-597656dab4b-fd5b-441c-b2cc-ab3a029b382212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-597GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 4 package rows20240615_bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787.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 CapsulePSNbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7877
198852simethicone 125 MG Oral CapsuleSCDbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7877
198852dimethicone 125 MG Oral CapsuleSYbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-597-304116305973030 BLISTER PACK in 1 CARTON (41163-597-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2019-11-290000-00-00NoNoCurrent
41163-597-504116305975050 BLISTER PACK in 1 CARTON (41163-597-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK50 blister pack2019-11-290000-00-00NoNoCurrent