Gas Relief Simethicone 125mg Softgel

Product NDC
84324-014
11-digit product format
843240014
Labeler code
84324
Product ID
84324-014_5b5f1c15-7b17-42be-b068-804e60596153
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NUVICARE LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
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

Additional Listing Data#

Finished product
Yes
Brand name base
Gas Relief Simethicone 125mg Softgel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198852

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-014-01Gas Relief Simethicone 125mg Softgel100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-014GAS RELIEF SIMETHICONE 125MG SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [NUVICARE LLC]1Current NDC, 1 package rows20240719_b774c8e6-e68e-4a13-834d-7eba34c5c3e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNb774c8e6-e68e-4a13-834d-7eba34c5c3e02
198852simethicone 125 MG Oral CapsuleSCDb774c8e6-e68e-4a13-834d-7eba34c5c3e02
198852dimethicone 125 MG Oral CapsuleSYb774c8e6-e68e-4a13-834d-7eba34c5c3e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84324-014-0184324001401100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01) 2024-07-18NoNoCurrent