Home NDC 55505-197 Kaopectate
Product NDC 55505-197
11-digit product format 555050197
Labeler code 55505
Product ID 55505-197_eb3ecda3-180e-4a04-9089-5cceabe22724
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, COATED
Route ORAL
Labeler Kramer Laboratories
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-01
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
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 Kaopectate
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 308760 Internal RxNorm lookup 642349 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 55505-197-07 Kaopectate 28 in 1 BOTTLE TABLET, COATED 28 8 55505-197-07 Kaopectate 1 in 1 CARTON TABLET, COATED 1 8 55505-197-70 Kaopectate 42 in 1 BOTTLE TABLET, COATED 42 8 55505-197-70 Kaopectate 1 in 1 CARTON TABLET, COATED 1 8 55505-197-77 Kaopectate 84 in 1 BOTTLE TABLET, COATED 84 8 55505-197-77 Kaopectate 1 in 1 CARTON TABLET, COATED 1 8 55505-197-78 Kaopectate 2 in 1 PACKAGE TABLET, COATED 2 8 55505-197-78 Kaopectate 1 in 1 CARTON TABLET, COATED 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-197 KAOPECTATE (BISMUTH SUBSALICYLATE) TABLET, COATED [KRAMER LABORATORIES] 6 Current NDC, Legacy NDC, 8 package rows 20250419_3877a88d-9546-48ce-ad6b-3c2a115e3eaf.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 55505-197-07 55505019707 1 BOTTLE in 1 CARTON (55505-197-07) / 28 TABLET, COATED in 1 BOTTLE 1 bottle 2020-10-01 0000-00-00 No No Current 55505-197-70 55505019770 1 BOTTLE in 1 CARTON (55505-197-70) / 42 TABLET, COATED in 1 BOTTLE 1 bottle 2021-02-01 0000-00-00 No No Current 55505-197-77 55505019777 1 BOTTLE in 1 CARTON (55505-197-77) / 84 TABLET, COATED in 1 BOTTLE 1 bottle 2025-11-15 No No Current 55505-197-78 55505019778 2 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE 2 carton 2025-04-23 No No Current