EXTRA STRENGTH

Product NDC
68163-700
11-digit product format
681630700
Labeler code
68163
Product ID
68163-700_411ba384-443e-b157-e063-6394a90ac3b9
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
LIQUID
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-26
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 mg/5mL
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
EXTRA STRENGTH
Brand name suffix
gas relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui2262288

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-700-08EXTRA STRENGTHgas relief237 mL in 1 BOTTLELIQUID2377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-700EXTRA STRENGTH GAS RELIEF (SIMETHICONE) LIQUID [RARITAN PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 1 package rows20241010_9af45664-adf4-49ce-987d-9314e9804a29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2262288simethicone 125 MG in 5 mL Oral SuspensionPSN9af45664-adf4-49ce-987d-9314e9804a297
2262288simethicone 25 MG/ML Oral SuspensionSCD9af45664-adf4-49ce-987d-9314e9804a297
2262288simethicone 125 MG per 5 ML Oral SuspensionSY9af45664-adf4-49ce-987d-9314e9804a297

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68163-700-0868163070008237 mL in 1 BOTTLE (68163-700-08) 237 ml2020-08-260000-00-00NoNoCurrent