Pepto

Product NDC
84126-378
11-digit product format
841260378
Labeler code
84126
Product ID
84126-378_48d6633a-4ef5-aa7a-e063-6294a90ab1d2
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-03
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
92RU3N3Y1ODIMETHICONE9006-65-9DIMETHICONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-378-16841260378161 BOTTLE, PLASTIC in 1 CARTON (84126-378-16) / 16 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2026-03-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pepto ® Gas + BloatingThe Procter & Gamble Manufacturing Company2026-01-20HUMAN OTC DRUG LABEL1