FDA.reportPublic FDA data

Gas Relief

Product NDC
55319-555
11-digit product format
553190555
Labeler code
55319
Product ID
55319-555_b50ee474-656d-4aa4-93ae-85383f2a32ce
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198852

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-555-30Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED16
55319-555-30Gas Relief30 in 1 CARTONCAPSULE, LIQUID FILLED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-555GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 2 package rows20240328_04736bb0-58fa-4d6d-ac0a-761c0429f85e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSN04736bb0-58fa-4d6d-ac0a-761c0429f85e6
198852simethicone 125 MG Oral CapsuleSCD04736bb0-58fa-4d6d-ac0a-761c0429f85e6
198852dimethicone 125 MG Oral CapsuleSY04736bb0-58fa-4d6d-ac0a-761c0429f85e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-555-305531905553030 BLISTER PACK in 1 CARTON (55319-555-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2023-07-01NoNoCurrent