TopCare Stomach Relief

Product NDC
36800-341
11-digit product format
368000341
Labeler code
36800
Product ID
36800-341_433b9bca-9b39-cacb-e063-6294a90a7523
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-14
Substance
BISMUTH SUBSALICYLATE
Active strength
525 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
TopCare Stomach Relief
Brand name suffix
Ultra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308763

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
36800-341-08TopCare Stomach ReliefUltra Strength236 mL in 1 BOTTLESUSPENSION2367
36800-341-12TopCare Stomach ReliefUltra Strength354 mL in 1 BOTTLESUSPENSION3547

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-341TOPCARE STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 2 package rows20241107_e745e693-9e45-43b0-b26c-99ca891b74b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNe745e693-9e45-43b0-b26c-99ca891b74b07
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDe745e693-9e45-43b0-b26c-99ca891b74b07
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYe745e693-9e45-43b0-b26c-99ca891b74b07
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYe745e693-9e45-43b0-b26c-99ca891b74b07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-341-0836800034108236 mL in 1 BOTTLE (36800-341-08) 236 ml2019-03-140000-00-00NoNoCurrent
36800-341-1236800034112354 mL in 1 BOTTLE (36800-341-12) 354 ml2019-03-140000-00-00NoNoCurrent