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

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 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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEAtlantic Biologicals Corp401f8393-680c-e1a8-e063-6394a90a81ab2025-10-01WarningsExact identifier
application number: M008
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgelBISMUTH SUBSALICYLATEStrive Pharmaceuticals Inc.0f271054-fa96-4475-8279-65f4565aba362025-09-22WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEFBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)67c610b1-fe94-4ad3-ad1a-8bd93a4da9d92025-09-11WarningsExact identifier
application number: M008
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M008
McKesson BismuthBISMUTH SUBSALICYLATEMcKesson Medical-Surgicald1f3dfa4-e021-6384-e053-2995a90a7b422025-09-08WarningsExact identifier
application number: M008
Medi-First Pep-T-MedBISMUTH SUBSALICYLATEUnifirst First Aid Corporation88f4d5d4-92ed-40ab-97a9-181da72f869b2025-09-08WarningsExact identifier
application number: M008
Thompson Chewable Bismuth TabsBISMUTH SUBSALICYLATEThompson Safety LLCc94b9bc2-b764-a9a7-e053-2a95a90aed812025-09-08WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f0588ab8-d1fc-419a-8d68-bee42332d50f2025-08-01WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338d61af-35a8-fba7-e063-6294a90a38e82025-07-21WarningsExact identifier
application number: M008
SennaSENNOSIDESMajor Pharmaceuticalscfb6bf89-c77e-4372-9bc9-44d6a659c9552025-07-18WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEMajor Pharmaceuticals2a7c9cc1-206e-4018-b89d-7b634df43df62025-07-11WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55440401-f82f-45a3-ba7e-6ccdfdacead32025-07-10WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGPioneer Life Sciences, LLC07e2cc82-ab0e-46c5-863b-67658b6126782025-06-27WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact 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