Gas Relief SIMETHICONE 250 mg Anti-gas

Product NDC
51316-702
11-digit product format
513160702
Labeler code
51316
Product ID
51316-702_2d80f49f-9771-a7d4-e063-6394a90a26de
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-08
Substance
DIMETHICONE
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
Gas Relief SIMETHICONE 250 mg Anti-gas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 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
2595235Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-702-08Gas Relief SIMETHICONE 250 mg Anti-gas20 in 1 BOTTLE, PLASTICTABLET, CHEWABLE204
51316-702-12Gas Relief SIMETHICONE 250 mg Anti-gas30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-702GAS RELIEF SIMETHICONE 250 MG ANTI-GAS (SIMETHICONE) TABLET, CHEWABLE [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 2 package rows20250209_63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595235simethicone 250 MG Chewable TabletPSN63dbc39e-2ba8-4435-9093-d1ad2eb3e8d54
2595235simethicone 250 MG Chewable TabletSCD63dbc39e-2ba8-4435-9093-d1ad2eb3e8d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-702-085131607020820 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51316-702-08) 2022-03-080000-00-00NoNoCurrent
51316-702-125131607021230 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51316-702-12) 2024-07-17NoNoCurrent