Home NDC 69423-963-48 Pepto Bismol
Product NDC 69423-963
Requested package NDC 69423-963-48
11-digit product format 694230963
Labeler code 69423
Product ID 69423-963_579c459a-830c-dc48-e063-6294a90a45bc
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-01
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
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 Chews
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 262 mg/1
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 211151 Internal RxNorm lookup 308761 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 69423-963-24 Pepto BismolChews 24 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 24 14 69423-963-48 Pepto BismolChews 48 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 48 14 69423-963-72 Pepto BismolChews 72 in 1 CELLO PACK TABLET, CHEWABLE 72 14 69423-963-72 Pepto BismolChews 24 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 24 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-963 PEPTO BISMOL CHEWS (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 11 Current NDC, Legacy NDC, 4 package rows 20250409_cfe9214d-25e9-7729-e053-2a95a90a0dfb.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 Marketing start Sample Exclude flag Status 69423-963-48 69423096348 48 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69423-963-48) 2025-12-01 No No Current