Home NDC 37000-441-16 Pepto-Bismol
Product NDC 37000-441
Requested package NDC 37000-441-16
11-digit product format 370000441
Labeler code 37000
Product ID 37000-441_463f92ab-5f79-b8da-e063-6294a90ad7ca
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form SUSPENSION
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-03-01
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
NDC exclude flag No
Listing certified through 2026-12-31
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-Bismol
Brand name suffix Ultra Cherry
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 62TEY51RR1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211915 Internal RxNorm lookup 308763 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37000-441-12 Pepto-BismolUltra Cherry 354 mL in 1 BOTTLE, PLASTIC SUSPENSION 354 11 37000-441-16 Pepto-BismolUltra Cherry 473 mL in 1 BOTTLE, PLASTIC SUSPENSION 473 11 37000-441-32 Pepto-BismolUltra Cherry 2 in 1 CARTON SUSPENSION 2 11 37000-441-32 Pepto-BismolUltra Cherry 473 mL in 1 BOTTLE, PLASTIC SUSPENSION 473 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37000-441 PEPTO-BISMOL ULTRA CHERRY (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 8 Current NDC, Legacy NDC, 4 package rows 20241012_6738f781-85a9-49a9-e053-2991aa0a786f.zip
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 12 · 223 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 37000-441-16 37000044116 473 mL in 1 BOTTLE, PLASTIC (37000-441-16) 473 ml 2025-08-03 No No Current