FDA.reportPublic FDA data

CVS PHARMACY

Product NDC
51316-110
11-digit product format
513160110
Labeler code
51316
Product ID
51316-110_ae481994-9f88-49b2-b56a-7bfb66f3d7a5
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-05
Substance
DIMETHICONE, UNSPECIFIED
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
CVS PHARMACY
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 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
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98db6216-897c-4cf6-a4b7-b913ae3a2496Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-110-00CVS PHARMACYExtra Strength100 in 1 CARTONTABLET, CHEWABLE1006
51316-110-18CVS PHARMACYExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE96
51316-110-18CVS PHARMACYExtra Strength2 in 1 CARTONTABLET, CHEWABLE26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-110CVS PHARMACY EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [CVS]5Current NDC, Legacy NDC, 3 package rows20240326_98db6216-897c-4cf6-a4b7-b913ae3a2496.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 9 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
application number: M002
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI5dae8bbe-219b-4aa1-bf7f-6471fa2856d92024-12-20WarningsExact identifier
application number: M002
GNP Stomach ReliefBISMUTH SUBSALICYLATE 525 MGAmerisource Bergenead13b6b-de37-49f9-b18e-68096651d47e2024-12-20WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFIa9902ba0-f239-4e66-8d66-7cef39a5fdc32024-12-20WarningsExact identifier
application number: M002
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergena6ed50d5-574f-4d6b-be48-e146593389932024-12-20WarningsExact identifier
application number: M002
WinCo Foods Gas Relief Extra Strength SoftgelsSIMETHICONEWinCo Foods, LLCa1a19ef7-4a14-4fcb-8917-631d867be0bb2024-12-18WarningsExact identifier
application number: M002
Discount Drugmart Gas Relief Extra Strength SoftgelsSIMETHICONEDiscount Drug Mart, Inc63f3e5f0-10da-4681-a4f1-8ca1eb7e390f2024-12-18WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association06dfb541-fd1f-4cee-a4a6-44252f1f65a02024-12-18WarningsExact identifier
application number: M002
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
application number: M002
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthDIMETHICONETOPCO ASSOCIATES LLCb9a4c876-722b-4d6c-807f-005ccf5df3202024-12-14WarningsExact identifier
application number: M002
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
application number: M002
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
application number: M002
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd0c9c5fec-ddd4-41a5-8ff9-6b55c376dd362024-11-25WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.f7c40b12-11e4-4b85-afb2-0ea33e4f218c2024-11-25WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN98db6216-897c-4cf6-a4b7-b913ae3a24966
314221simethicone 125 MG Chewable TabletSCD98db6216-897c-4cf6-a4b7-b913ae3a24966

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-110-0051316011000100 TABLET, CHEWABLE in 1 CARTON (51316-110-00) 2023-10-23NoNoCurrent
51316-110-18513160110182 BLISTER PACK in 1 CARTON (51316-110-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2021-08-050000-00-00NoNoCurrent