Simethicone

Product NDC
17714-076
11-digit product format
177140076
Labeler code
17714
Product ID
17714-076_2a3255ec-164d-c398-e063-6394a90a5a02
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
GEL
Route
ORAL
Labeler
Advance Pharmaceutical Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-11
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

Additional Listing Data#

Finished product
Yes
Brand name base
Simethicone
Brand name suffix
Certified Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17714-076-18SimethiconeCertified Plus180 in 1 BOTTLEGEL1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-076SIMETHICONE CERTIFIED PLUS (SIMETHICONE) GEL [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 1 package rows20241228_d087743f-b82f-2a5c-e053-2995a90abb20.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17714-076-1817714007618180 GEL in 1 BOTTLE (17714-076-18) 180 gel2021-11-110000-00-00NoNoCurrent