FDA.reportPublic FDA data

Gas Relief

Product NDC
51316-597
11-digit product format
513160597
Labeler code
51316
Product ID
51316-597_37e6d1e0-23cb-4f69-acdf-bfa8b157d16c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-30
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
4ff77b4c-9616-4341-9bf8-eca301345a5fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-597-12Gas Relief120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1209
51316-597-12Gas Relief1 in 1 BOXCAPSULE, LIQUID FILLED19
51316-597-20Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED19
51316-597-20Gas Relief72 in 1 CARTONCAPSULE, LIQUID FILLED729
51316-597-30Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED19
51316-597-30Gas Relief30 in 1 CARTONCAPSULE, LIQUID FILLED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-597GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]4Current NDC, 6 package rows20231223_4ff77b4c-9616-4341-9bf8-eca301345a5f.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 11 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
application number: M002
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
application number: M002
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
application number: M002
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreensaa074ceb-b86e-4a07-b885-b8fa6c1e0fcf2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens3e5821ec-d096-4f52-82d2-475056f45e4c2024-06-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEWalgreens0050b639-5fb6-4503-ae73-e319cf0370272024-06-26WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC853f5f52-8fe1-473f-b68d-2951152221202024-05-31WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEA-S Medication Solutions708cbbf2-4923-4cbf-b71c-c8bb2ce80e632024-05-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIa7961933-9d74-4c18-8050-2cc13cb6725e2024-05-23WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONESafeway, Inc.8927d9eb-65b2-40f3-846c-dc9cd2884dea2024-05-14WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff50f5-4195-a61f-e053-6294a90a8bdf2024-05-13WarningsExact identifier
application number: M002
simethicone gas reliefSIMETHICONEMOM Enterprises, LCC536ecfdf-7124-502a-e054-00144ff8d46c2024-04-09WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN4ff77b4c-9616-4341-9bf8-eca301345a5f9
198852simethicone 125 MG Oral CapsuleSCD4ff77b4c-9616-4341-9bf8-eca301345a5f9
198852dimethicone 125 MG Oral CapsuleSY4ff77b4c-9616-4341-9bf8-eca301345a5f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-597-12513160597121 BOTTLE, PLASTIC in 1 BOX (51316-597-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-11-30NoNoCurrent
51316-597-205131605972072 BLISTER PACK in 1 CARTON (51316-597-20) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK72 blister pack2023-11-30NoNoCurrent
51316-597-305131605973030 BLISTER PACK in 1 CARTON (51316-597-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2023-11-30NoNoCurrent