Home NDC 53117-046 Pep Tum
Product NDC 53117-046
11-digit product format 531170046
Labeler code 53117
Product ID 53117-046_affef754-2097-48fc-975b-63a35c991da7
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler First Aid Direct
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
Substance BISMUTH SUBSALICYLATE
Active strength 262 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 Pep Tum
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 53117-046-85 Pep Tum 1 in 1 CELLO PACK TABLET, CHEWABLE 1 8 53117-046-85 Pep Tum 30 in 1 CARTON TABLET, CHEWABLE 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53117-046 PEP TUM (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [FIRST AID DIRECT] 8 Current NDC, Legacy NDC, 2 package rows 20231020_bf966e9f-2f95-41cd-a6e5-b8eb521181d8.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 53117-046-85 53117004685 30 CELLO PACK in 1 CARTON (53117-046-85) / 1 TABLET, CHEWABLE in 1 CELLO PACK 30 cello pack 2014-12-23 0000-00-00 No No Current