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 5 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6701200-eb58-30f1-e053-2a95a90a032e2025-12-10WarningsExact identifier
application number: M002
Motion Sickness ReliefMECLIZINE HCLShield Pharmaceuticals Corp9b5ad2ca-a47b-434a-97b5-8f729740d4ee2025-12-09WarningsExact identifier
application number: M002
CVS Health Maximum StrengthANTACID AND ANTIGASCVS Pharmacy,Inc.0a13ac81-0c63-48c1-bbb0-f6e67f97b8962025-12-04WarningsExact identifier
application number: M002
Quality Choice Infants Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
application number: M002
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
application number: M002
QC Gas Relief Mint FlavorSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)26b83259-744b-4711-a32f-9f8fe5d0555b2025-12-03WarningsExact identifier
application number: M002
Walgreens Infants Dye Free Gas ReliefSIMETHICONEWALGREEN CO.05d2a37f-f47d-40e6-a799-120d846bf5d62025-12-02WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association849802d6-698d-479b-9036-781317a59ade2025-12-02WarningsExact identifier
application number: M002
Walgreens Extra StrengthSIMETHICONEWALGREENS CO.dbd2ed5b-14b1-4bdf-bd0a-84579ca3d8152025-11-25WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASWALGREENS CO.bf6f5463-a88c-4854-be4d-319582e564792025-11-25WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEBJWC (Berkley & Jensen / BJ's)0198f55b-735d-4354-83aa-acdc644af2c92025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEMajor Pharmaceuticals4f445be1-220d-4660-abb2-c24cd33e7ca72025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECardinal Health (Leader) 700004ce6d62c-9321-4b11-94ea-c51a94f351812025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact 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