Home NDC 37000-538 Pepto
Product NDC 37000-538
11-digit product format 370000538
Labeler code 37000
Product ID 37000-538_eeb38418-92fb-4372-e053-2a95a90a67f2
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 FINAL
Marketing start 2018-03-01
Marketing end 0000-00-00
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 37000-538-04 PeptoDiarrhea 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37000-538 PEPTO DIARRHEA (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 10 Legacy NDC, 1 package rows 20231129_8517edac-fda7-7a49-e053-2a91aa0a24cd.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 4 of 10 · 198 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 37000-538-04 37000053804 118 mL in 1 BOTTLE, PLASTIC (37000-538-04) 118 ml 2019-03-01 0000-00-00 No No Current