Home NDC 69423-966-12 Pepto Bismol
Product NDC 69423-966
Requested package NDC 69423-966-12
11-digit product format 694230966
Labeler code 69423
Product ID 69423-966_5b0ffda7-919a-3d28-e063-6394a90a7723
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 2022-03-07
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
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 Bismol
Brand name suffix Ultra
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69423-966-12 Pepto BismolUltra 354 mL in 1 BOTTLE, PLASTIC SUSPENSION 354 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-966 PEPTO BISMOL ULTRA (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 6 Current NDC, Legacy NDC, 1 package rows 20241012_d800eb8c-42c8-fb12-e053-2a95a90af2a2.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 Marketing end Sample Exclude flag Status 69423-966-12 69423096612 354 mL in 1 BOTTLE, PLASTIC (69423-966-12) 354 ml 2022-03-07 0000-00-00 No No Current