FDA.reportPublic FDA data

TopCare

Product NDC
36800-661
11-digit product format
368000661
Labeler code
36800
Product ID
36800-661_433b7a06-ddb7-da11-e063-6294a90a65ae
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
2019-05-07
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-661-08TopCareRegular Strength236 mL in 1 BOTTLESUSPENSION2367
36800-661-16TopCareRegular Strength473 mL in 1 BOTTLESUSPENSION4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-661TOPCARE REGULAR STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 2 package rows20241107_2619720a-d926-4b17-899c-54d49c78802c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2619720a-d926-4b17-899c-54d49c78802c7
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2619720a-d926-4b17-899c-54d49c78802c7
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2619720a-d926-4b17-899c-54d49c78802c7
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2619720a-d926-4b17-899c-54d49c78802c7
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2619720a-d926-4b17-899c-54d49c78802c7
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2619720a-d926-4b17-899c-54d49c78802c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-661-0836800066108236 mL in 1 BOTTLE (36800-661-08) 236 ml2019-05-070000-00-00NoNoCurrent
36800-661-1636800066116473 mL in 1 BOTTLE (36800-661-16) 473 ml2019-05-070000-00-00NoNoCurrent