Home NDC 84126-378 Pepto
Product NDC 84126-378
11-digit product format 841260378
Labeler code 84126
Product ID 84126-378_5d1b52f5-6ea3-d5ce-e063-6394a90ae13c
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pepto
Brand name suffix Gas plus Bloating
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-378-16 PeptoGas plus Bloating 1 in 1 CARTON TABLET, CHEWABLE 1 1 84126-378-16 PeptoGas plus Bloating 16 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 16 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 12 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84126-378-16 84126037816 1 BOTTLE, PLASTIC in 1 CARTON (84126-378-16) / 16 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2026-03-03 No No Current