Home NDC 55505-229 Kaopectate
Product NDC 55505-229
11-digit product format 555050229
Labeler code 55505
Product ID 55505-229_c7ad4e0a-96fb-4cb5-998d-0b055155eae2
Type HUMAN OTC DRUG
Nonproprietary name Bismuth Subsalicylate
Dosage form LIQUID
Route ORAL
Labeler KRAMER LABORATORIES
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-01
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/15mL
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 Kaopectate
Listing expiration 2026-12-31
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 308763 Internal RxNorm lookup 1043048 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 55505-229-64 Kaopectate 325 mL in 1 BOTTLE LIQUID 325 1
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 Sample Exclude flag Status 55505-229-64 55505022964 325 mL in 1 BOTTLE (55505-229-64) 325 ml 2026-02-01 No No Current