FDA.reportPublic FDA data

Kaopectate Peppermint Flavor Anti Diarrheal

Product NDC
55505-199
11-digit product format
555050199
Labeler code
55505
Product ID
55505-199_7661cb13-fcaa-4bbe-a803-8ecb666550d7
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55505-19955505-199-64DDiscontinued by firm2026-10-15

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 Peppermint 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
0316f469-e9fa-47c3-bb20-bd4588b40bccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-199-36Kaopectate Peppermint Flavor Anti Diarrheal236 mL in 1 BOTTLELIQUID2366
55505-199-64Kaopectate Peppermint Flavor Anti Diarrheal325 mL in 1 BOTTLELIQUID3256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-199-64ML - Milliliter55505-1995effe60a-376b-4b22-a1a4-3e7e77452fe212026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-199KAOPECTATE PEPPERMINT FLAVOR ANTI DIARRHEAL (BISMUTH SUBSALICYLATE) LIQUID [KRAMER LABORATORIES]5Current NDC, Legacy NDC, 2 package rows20241212_0316f469-e9fa-47c3-bb20-bd4588b40bcc.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 9 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RITE AID Ultra Strnght Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION3ffb2bb9-6d6a-4c38-ac59-0ac0d754de282024-10-30WarningsExact identifier
application number: M008
Premier Value Diarrhea Relief Vanilla FlavorBISMUTH SUBSALICYLATEPHARMACY VALUE ALLIANCE, LLC1c6e464c-d5c6-4658-a0d8-bba87369a0c32024-10-28WarningsExact identifier
application number: M008
Premier ValueBISMUTH SUBSALICYLATECHAIN DRUG CONSORTIUM,LLC3b8850e8-f9c2-4d52-aadd-8e037fabdee42024-10-28WarningsExact identifier
application number: M008
Goodsense maximum strength Stomach Relief 528BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a4191a-6196-f8ac-e063-6394a90a47ab2024-09-17WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)5ecc500c-12d0-41dd-acb4-9190023c9ed52024-09-16WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEBest Choice (Valu Merchandisers Company)ecbf9caf-b02b-434e-8f29-50839010e8212024-09-16WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEGood Sense (Geiss, Destin & Dunn, Inc.)19a324bd-fa54-b899-e063-6394a90aaa732024-09-10WarningsExact identifier
application number: M008
Ultra BismuthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0fc01a1a-4b1d-4c78-9955-220984a8019c2024-08-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b22e1a0f-9866-403b-93e8-6e0e4130a75e2024-08-29WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATERugby Laboratories, Inc.87394088-1d2e-4ca4-bbfe-1481c9d4a3ba2024-08-29WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreensa2b2b0ce-034e-4857-bfca-0087bb31878e2024-07-25WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07aa10e2-dd03-f32d-e063-6294a90aad0d2024-06-26WarningsExact identifier
application number: M008
Stomach ReliefSTOMACH RELIEFChain Drug Marketing Association, Inc.459abf99-63e8-43d7-a13c-9e46826984152024-06-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEStrategic Sourcing Services LLC2a018350-da22-4997-9181-661bb920afd32024-06-04WarningsExact identifier
application number: M008
5 Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION07a932fb-38eb-4b35-e063-6394a90ad61f2024-05-25WarningsExact identifier
application number: M008
Soothe Ultra StrengthBISMUTH SUBSALICYLATEWalgreensec96e6f2-b087-457e-9b95-30f3595deebb2024-05-21WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATESafeway, Inc.2bde4e41-ffbd-4d9d-ae00-e39a5c7264b32024-05-15WarningsExact identifier
application number: M008
Ultra Stomach ReliefBISMUTH SUBSALICYLATESafeway, Inc.71ca1c0e-50dc-4970-ae0d-5f7be1eec6df2024-05-15WarningsExact identifier
application number: M008
PEPT-ACHEBISMUTH SUBSALICYLATEJHK Inc dba American Safety & First Aid894c1912-cd24-4ddf-b7e7-dae9dd64b2802024-04-24WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEP & L Development, LLCcb5ca7ab-39cf-4b07-ac22-a00b214db1022024-04-16WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN0316f469-e9fa-47c3-bb20-bd4588b40bcc6
642346Kaopectate 262 MG in 15 mL Oral Suspension, Reformulated Aug 2006PSN0316f469-e9fa-47c3-bb20-bd4588b40bcc6
642346bismuth subsalicylate 17.5 MG/ML Oral Suspension [Kaopectate Reformulated Aug 2006]SBD0316f469-e9fa-47c3-bb20-bd4588b40bcc6
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD0316f469-e9fa-47c3-bb20-bd4588b40bcc6
308762bismuth subsalicylate 1.75 % Oral SuspensionSY0316f469-e9fa-47c3-bb20-bd4588b40bcc6
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY0316f469-e9fa-47c3-bb20-bd4588b40bcc6
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY0316f469-e9fa-47c3-bb20-bd4588b40bcc6
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY0316f469-e9fa-47c3-bb20-bd4588b40bcc6
642346Kaopectate 262 MG per 15 ML Oral Suspension, Reformulated Aug 2006SY0316f469-e9fa-47c3-bb20-bd4588b40bcc6
642346Kaopectate Reformulated Aug 2006 17.5 MG/ML Oral SuspensionSY0316f469-e9fa-47c3-bb20-bd4588b40bcc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-199-3655505019936236 mL in 1 BOTTLE (55505-199-36) 236 ml2020-10-010000-00-00NoNoCurrent
55505-199-6455505019964325 mL in 1 BOTTLE (55505-199-64) 325 ml2022-03-010000-00-00NoNoCurrent