FDA.reportPublic FDA data

Gas Relief

Product NDC
83455-152
11-digit product format
834550152
Labeler code
83455
Product ID
83455-152_806dc9d8-230c-436a-b3f5-05051490c47e
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83455-152-60Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED603
83455-152-60Gas Relief1 in 1 BOXCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-152GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI]2Current NDC, 2 package rows20240109_33700cc7-48bc-4174-9f9a-36a50b4c91f3.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 CapsulePSN33700cc7-48bc-4174-9f9a-36a50b4c91f33
252294simethicone 180 MG Oral CapsuleSCD33700cc7-48bc-4174-9f9a-36a50b4c91f33
252294dimethicone 180 MG Oral CapsuleSY33700cc7-48bc-4174-9f9a-36a50b4c91f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83455-152-60834550152601 BOTTLE, PLASTIC in 1 BOX (83455-152-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-12-31NoNoCurrent