Gas relief

Product NDC
53943-301
11-digit product format
539430301
Labeler code
53943
Product ID
53943-301_5101eb45-8cb8-4410-9553-3b1b73a7e9b1
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Discount Drug Mart, Inc
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-14
Substance
DIMETHICONE
Active strength
80 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 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
314216Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2df9117a-97cc-532d-e063-6294a90a1a9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-301-16Gas relief100 in 1 BOTTLETABLET, CHEWABLE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-301GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [DISCOUNT DRUG MART, INC]2Current NDC, 1 package rows20250223_2df9117a-97cc-532d-e063-6294a90a1a9c.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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
application number: M002
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
application number: M002
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSN2df9117a-97cc-532d-e063-6294a90a1a9c2
314216simethicone 80 MG Chewable TabletSCD2df9117a-97cc-532d-e063-6294a90a1a9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53943-301-1653943030116100 TABLET, CHEWABLE in 1 BOTTLE (53943-301-16) 2025-02-14NoNoCurrent