Home NDC 84126-368 Pepto
Product NDC 84126-368
11-digit product format 841260368
Labeler code 84126
Product ID 84126-368_5b22dd76-be2d-0a31-e063-6294a90a08f4
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-01
Substance DIMETHICONE
Active strength 250 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 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 412111 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-368-24 PeptoGas plus Bloating 24 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 24 1 84126-368-24 PeptoGas plus Bloating 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 84126-368-50 PeptoGas plus Bloating 50 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 50 1 84126-368-50 PeptoGas plus Bloating 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 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 1 of 13 · 255 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 84126-368-24 84126036824 1 BOTTLE, PLASTIC in 1 CARTON (84126-368-24) / 24 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2026-03-02 No No Current 84126-368-50 84126036850 1 BOTTLE, PLASTIC in 1 CARTON (84126-368-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2025-10-01 No No Current