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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762, 642346

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

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