Home NDC 58933-478 Pepto-Bismol
Product NDC 58933-478
11-digit product format 589330478
Labeler code 58933
Product ID 58933-478_40be321b-5e7e-14b6-e063-6294a90ab11f
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET
Route ORAL
Labeler Procter & Gamble Manufactura, S. de R.L. de C.V.
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-01
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/1
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 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 1998447 Internal RxNorm lookup 1998449 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 58933-478-12 Pepto-BismolULTRA 12 in 1 BOTTLE TABLET 12 10 58933-478-12 Pepto-BismolULTRA 1 in 1 CARTON TABLET 1 10 58933-478-24 Pepto-BismolULTRA 1 in 1 CARTON TABLET 1 10 58933-478-24 Pepto-BismolULTRA 24 in 1 BOTTLE TABLET 24 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58933-478 PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA, S. DE R.L. DE C.V.] 9 Current NDC, Legacy NDC, 4 package rows 20241012_63283ebc-cff8-07d4-e053-2a91aa0a9de0.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 58933-478-12 58933047812 1 BOTTLE in 1 CARTON (58933-478-12) / 12 TABLET in 1 BOTTLE 1 bottle 2018-02-01 0000-00-00 No No Current 58933-478-24 58933047824 1 BOTTLE in 1 CARTON (58933-478-24) / 24 TABLET in 1 BOTTLE 1 bottle 2018-02-01 0000-00-00 No No Current