FDA.reportPublic FDA data

Gas Relief

Product NDC
69168-433
11-digit product format
691680433
Labeler code
69168
Product ID
69168-433_b75ef1f0-789a-416a-a37f-0c93516a5310
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-01
Substance
DIMETHICONE
Active strength
180 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
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
4c79535c-4372-4fd4-a91a-d93617cd581bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-433-06Gas Relief120 in 1 BOTTLECAPSULE, LIQUID FILLED1205
69168-433-17Gas Relief300 in 1 BOTTLECAPSULE, LIQUID FILLED3005
69168-433-60Gas Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-433GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 3 package rows20241208_4c79535c-4372-4fd4-a91a-d93617cd581b.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252294simethicone 180 MG Oral CapsulePSN4c79535c-4372-4fd4-a91a-d93617cd581b5
252294simethicone 180 MG Oral CapsuleSCD4c79535c-4372-4fd4-a91a-d93617cd581b5
252294dimethicone 180 MG Oral CapsuleSY4c79535c-4372-4fd4-a91a-d93617cd581b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-433-0669168043306120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-433-06) 2021-10-150000-00-00NoNoCurrent
69168-433-1769168043317300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-433-17) 2022-03-230000-00-00NoNoCurrent
69168-433-606916804336060 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-433-60) 2023-11-06NoNoCurrent