Infants Gas relief

Product NDC
36800-119
11-digit product format
368000119
Labeler code
36800
Product ID
36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4a
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Topco Associates, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
DIMETHICONE
Active strength
20 mg/.3mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
92RU3N3Y1ODIMETHICONE9006-65-9DIMETHICONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36800-119-09368000119091 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER2013-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Topco Infants Gas Relief DropsTopco Associates, LLC | Guardian Drug Company2024-12-26Human OTC Drug Label2