FDA.reportPublic FDA data

gas relief

Product NDC
62011-0189
11-digit product format
620110189
Labeler code
62011
Product ID
62011-0189_41f6fdba-cb0f-4ea7-90a3-c0b9f86d1b3c
Type
HUMAN OTC DRUG
Nonproprietary name
simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-21
Substance
DIMETHICONE
Active strength
125 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
DIMETHICONE125 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
23005295-c5f2-4a76-8431-4a9b8d817d4dAvailable 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0189-1gas relief2 in 1 CARTONTABLET, CHEWABLE25
62011-0189-1gas relief9 in 1 BLISTER PACKTABLET, CHEWABLE95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0189-1EA - Each62011-01898a04e59d-bb20-4f20-82d2-b2e35582329012013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
SORBITOLINACTIVE INGREDIENT506T60A25RGAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1
SUCROSEINACTIVE INGREDIENTC151H8M554GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [HEALTH MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0189GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 2 package rows20250105_23005295-c5f2-4a76-8431-4a9b8d817d4d.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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN23005295-c5f2-4a76-8431-4a9b8d817d4d5
314221simethicone 125 MG Chewable TabletSCD23005295-c5f2-4a76-8431-4a9b8d817d4d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0189-1620110189012 BLISTER PACK in 1 CARTON (62011-0189-1) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-10-210000-00-00NoNoCurrent