Topcare Ultra Strength Stomach Relief

Product NDC
76162-022
11-digit product format
761620022
Labeler code
76162
Product ID
76162-022_4c92ba55-f626-45cd-86a4-6a94bbe73187
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Topco Associates, LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-05
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Ultra Strength Stomach Relief
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
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
76162-022-04Topcare Ultra Strength Stomach Relief236 mL in 1 BOTTLELIQUID2363
76162-022-05Topcare Ultra Strength Stomach Relief354 mL in 1 BOTTLELIQUID3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-022TOPCARE ULTRA STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [TOPCO ASSOCIATES, LLC]3Current NDC, Legacy NDC, 2 package rows20241211_908da10c-2ed1-4917-a98b-bab63d7990d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN908da10c-2ed1-4917-a98b-bab63d7990d43
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD908da10c-2ed1-4917-a98b-bab63d7990d43
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY908da10c-2ed1-4917-a98b-bab63d7990d43
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY908da10c-2ed1-4917-a98b-bab63d7990d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-022-0476162002204236 mL in 1 BOTTLE (76162-022-04) 236 ml2022-01-050000-00-00NoNoCurrent
76162-022-0576162002205354 mL in 1 BOTTLE (76162-022-05) 354 ml2022-01-050000-00-00NoNoCurrent