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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup
642346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ad310c8-3dfa-4435-87bf-17f1c0a9ca45Available on FDA.report

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

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 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companybb8d2ed8-54a2-2295-e053-2995a90a10ac2026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company252b143f-eee8-f407-e063-6394a90a0a082026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d20af4fb-d579-4d1e-86ae-342933f4de752026-07-15WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWALMART INC. (see also Equate)369fe912-dd0e-4ff3-a597-5ee81332838a2026-07-15WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)642c14bd-be99-410b-9ba7-6e71c97052302026-07-15WarningsExact identifier
application number: M008
Good Neighbor Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEAMERISOURCE BERGEN71c30b10-db24-4a42-a4f4-db552e3d5fe62026-07-13WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATESelect Consumer Group5611c6cb-5c0b-cf4e-e063-6394a90abff82026-07-07WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens394e16b8-dd7c-4c68-86ce-3623936745a72026-06-25WarningsExact identifier
application number: M008
Stomach Relief regular strengthBISMUTH SUBSALICYLATECVS Pharmacy1aa386ac-8ffd-4ba4-9b2e-19156d374c482026-06-25WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWalgreensc367d913-e37b-467a-84da-dd6a22c793ae2026-06-25WarningsExact identifier
application number: M008
Bismuth Subsalicylate Pink BismuthBISMUTH SUBSALICYLATEHyvee Inc4e575573-9ded-bfbf-e063-6394a90aed3b2026-06-23WarningsExact identifier
application number: M008
Stomach relieverBISMUTH SUBSALICYLATEHyvee Inc44ead6e1-cd88-4602-e063-6394a90aed9f2026-06-16WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f7627bf1-da97-4875-b614-5029663f74822026-06-08WarningsExact identifier
application number: M008

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 bottle2025-06-01NoNoCurrent