CVS Health Gas Relief SOFTGEL

Product NDC
51316-311
11-digit product format
513160311
Labeler code
51316
Product ID
51316-311_d49a110f-0766-4312-9827-0e2106c5d5f5
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
2025-01-31
Substance
DIMETHICONE, UNSPECIFIED
Active strength
250 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
CVS Health Gas Relief SOFTGEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED250 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
412111Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2911cac8-45ec-1294-e063-6294a90a4a74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-311-05CVS Health Gas Relief SOFTGEL25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED253
51316-311-05CVS Health Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED23
51316-311-30CVS Health Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED23
51316-311-30CVS Health Gas Relief SOFTGEL15 in 1 BLISTER PACKCAPSULE, LIQUID FILLED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-311CVS HEALTH GAS RELIEF SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]2Current NDC, 4 package rows20250206_2911cac8-45ec-1294-e063-6294a90a4a74.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 1 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
application number: M002
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
application number: M002
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
application number: M002
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
application number: M002
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
application number: M002
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
application number: M002
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
application number: M002
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
application number: M002
Infants Gas Relief Dye FreeSIMETHICONE ANTIGASTHE KROGER CO.722c8226-6556-4150-9fda-91be2b31183f2026-08-31WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
application number: M002
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
application number: M002
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
application number: M002
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
application number: M002
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
application number: M002
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
application number: M002
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
application number: M002
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
application number: M002
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
application number: M002
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412111simethicone 250 MG Oral CapsulePSN2911cac8-45ec-1294-e063-6294a90a4a743
412111simethicone 250 MG Oral CapsuleSCD2911cac8-45ec-1294-e063-6294a90a4a743
412111dimethicone 250 MG Oral CapsuleSY2911cac8-45ec-1294-e063-6294a90a4a743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-311-05513160311052 BLISTER PACK in 1 CARTON (51316-311-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-09-09NoNoCurrent
51316-311-30513160311302 BLISTER PACK in 1 CARTON (51316-311-30) / 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-01-31NoNoCurrent