FDA.reportPublic FDA data

Kaopectate Vanilla Flavor Anti Diarrheal

Product NDC
55505-198
11-digit product format
555050198
Labeler code
55505
Product ID
55505-198_e768f8f0-e5a9-4b19-b32b-396671dafc27
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
2020-10-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
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 Vanilla Flavor Anti Diarrheal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762, 642346

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
55505-198-36Kaopectate Vanilla Flavor Anti Diarrheal236 mL in 1 BOTTLELIQUID2367
55505-198-64Kaopectate Vanilla Flavor Anti Diarrheal325 mL in 1 BOTTLELIQUID3257
55505-198-82Kaopectate Vanilla Flavor Anti Diarrheal2 in 1 PACKAGELIQUID27
55505-198-82Kaopectate Vanilla Flavor Anti Diarrheal325 mL in 1 BOTTLELIQUID3257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-198-36ML - Milliliter55505-198d0cddd82-39d9-4a9f-ae5b-7c26173a022612026-02-05
55505-198-64ML - Milliliter55505-19862fdb466-3443-4441-8c1c-46222619e02d12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-198KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL (BISMUTH SUBSALICYLATE) LIQUID [KRAMER LABORATORIES]6Current NDC, Legacy NDC, 4 package rows20250419_3ad310c8-3dfa-4435-87bf-17f1c0a9ca45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
642346Kaopectate 262 MG in 15 mL Oral Suspension, Reformulated Aug 2006PSN3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
642346bismuth subsalicylate 17.5 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]SBD3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
642346Kaopectate 262 MG per 15 ML Oral Suspension, Reformulated Aug 2006SY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457
642346Kaopectate Reformulated Aug 2006 17.5 MG/ML Oral SuspensionSY3ad310c8-3dfa-4435-87bf-17f1c0a9ca457

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-198-3655505019836236 mL in 1 BOTTLE (55505-198-36) 236 ml2020-10-010000-00-00NoNoCurrent
55505-198-6455505019864325 mL in 1 BOTTLE (55505-198-64) 325 ml2022-02-010000-00-00NoNoCurrent
55505-198-82555050198822 BOTTLE in 1 PACKAGE (55505-198-82) / 325 mL in 1 BOTTLE2 bottle2025-06-01NoNoHistorical