FDA.reportPublic FDA data

Kaopectate

Product NDC
55505-206
11-digit product format
555050206
Labeler code
55505
Product ID
55505-206_6fd63db3-b84f-407f-b656-80f86ad420d1
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kramer Laboratories
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kaopectate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308761, 2476644

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-206-69Kaopectate24 in 1 BOTTLETABLET, CHEWABLE245
55505-206-69Kaopectate1 in 1 CARTONTABLET, CHEWABLE15
55505-206-79Kaopectate1 in 1 CARTONTABLET, CHEWABLE15
55505-206-79Kaopectate2 in 1 PACKAGETABLET, CHEWABLE25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-206KAOPECTATE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [KRAMER LABORATORIES]4Current NDC, Legacy NDC, 4 package rows20250419_2f6766a1-d775-40bf-a039-975ab47fcceb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN2f6766a1-d775-40bf-a039-975ab47fcceb5
2476644Kaopectate 262 MG Chewable Tablet, Reformulated Aug 2006PSN2f6766a1-d775-40bf-a039-975ab47fcceb5
2476644bismuth subsalicylate 262 MG Chewable Tablet [Kaopectate Reformulated Aug 2006]SBD2f6766a1-d775-40bf-a039-975ab47fcceb5
308761bismuth subsalicylate 262 MG Chewable TabletSCD2f6766a1-d775-40bf-a039-975ab47fcceb5
2476644Kaopectate Reformulated Aug 2006 262 MG Chewable TabletSY2f6766a1-d775-40bf-a039-975ab47fcceb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-206-69555050206691 BOTTLE in 1 CARTON (55505-206-69) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2021-02-010000-00-00NoNoCurrent
55505-206-79555050206792 CARTON in 1 PACKAGE (55505-206-79) / 1 BOTTLE in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE2 carton2025-06-01NoNoHistorical