FDA.reportPublic FDA data

Gas Relief

Product NDC
69842-832
11-digit product format
698420832
Labeler code
69842
Product ID
69842-832_3bdb3a43-8820-45c3-b784-9885aa63826c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-31
Substance
DIMETHICONE
Active strength
180 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
Brand name suffix
Ultra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 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
252294Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bac06147-87ae-4aaa-a66b-4aeae6096d8dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69842-832-202020-10-26Drug Facts
69842-832-602020-10-26Drug Facts
69842-832-202020-09-27Drug Facts
69842-832-602020-09-27Drug Facts
69842-832-202020-09-25Drug Facts
69842-832-602020-09-25Drug Facts
69842-832-202020-07-22Drug Facts
69842-832-602020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-832-20Gas ReliefUltra Strength20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED204
69842-832-20Gas ReliefUltra Strength1 in 1 BOXCAPSULE, LIQUID FILLED14
69842-832-60Gas ReliefUltra Strength1 in 1 BOXCAPSULE, LIQUID FILLED14
69842-832-60Gas ReliefUltra Strength60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-832GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20240315_bac06147-87ae-4aaa-a66b-4aeae6096d8d.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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd346df37d-b0fc-4fa5-8c19-492fed58c2392024-11-25WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONERetail Business Services, LLC.1e8ed36d-5236-163b-e063-6294a90ad6ec2024-11-22WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.0f9639fa-e1d0-460d-bc46-714a01cd98112024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.852cec3b-6564-46b2-afe5-ecef314242372024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.d33e413d-4add-459f-ba46-c23b49cfcc872024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreen Co.d87a20d4-dd1d-4897-9321-f81df2cfbcc72024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.b14b647f-d729-47df-879d-ca08a30b995e2024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWal-Mart Stores Inc206d57ec-c854-496e-af53-7d8b2a208d852024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALGREEN CO.4d523979-e3ae-47e8-9092-00fdffc8bb0b2024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWal-Mart Stores Inc69351cf9-3092-45ca-8b84-83e3737fa8d42024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALMART INC.79a9e0a3-9199-4397-ab29-b8a9c843cdf82024-11-21WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEFOODHOLD U.S.A., LLCc37def6e-bb10-41ba-8bce-b06c09edbe9f2024-11-21WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONE 180 MGHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.2cfb8132-6de4-457d-880b-c870a38862ad2024-11-20WarningsExact identifier
application number: M002
Gas-AidSIMETHICONELeosons Overseas Corpd271bfcb-bf13-4a97-bc03-f1824826f15a2024-11-19WarningsExact identifier
application number: M002
Gas-Aid Drops for infantsSIMETHICONELeosons Overseas Corp06665701-5f1c-4f8f-8775-e0a4a9ef20292024-11-19WarningsExact identifier
application number: M002
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
application number: M002
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
application number: M002
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
application number: M002
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSNbac06147-87ae-4aaa-a66b-4aeae6096d8d4
252294simethicone 180 MG Oral CapsuleSCDbac06147-87ae-4aaa-a66b-4aeae6096d8d4
252294dimethicone 180 MG Oral CapsuleSYbac06147-87ae-4aaa-a66b-4aeae6096d8d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-832-20698420832201 BOTTLE, PLASTIC in 1 BOX (69842-832-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent
69842-832-60698420832601 BOTTLE, PLASTIC in 1 BOX (69842-832-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent