Topcare Stomach Relief

Product NDC
76162-001
11-digit product format
761620001
Labeler code
76162
Product ID
76162-001_cfa0f68a-3278-47da-80b3-64e17d97fa35
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
TopCo Associates, LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
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
Original Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308761

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
76162-001-85Topcare Stomach ReliefOriginal Strength6 in 1 CARTONTABLET68
76162-001-85Topcare Stomach ReliefOriginal Strength5 in 1 BLISTER PACKTABLET58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-001TOPCARE STOMACH RELIEF ORIGINAL STRENGTH (BISMUTH SUBSALICYLATE) TABLET [TOPCO ASSOCIATES, LLC]8Current NDC, Legacy NDC, 2 package rows20231018_e4b1929c-0967-44ea-8552-6549aa2a464e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSNe4b1929c-0967-44ea-8552-6549aa2a464e8
308761bismuth subsalicylate 262 MG Chewable TabletSCDe4b1929c-0967-44ea-8552-6549aa2a464e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-001-85761620001856 BLISTER PACK in 1 CARTON (76162-001-85) / 5 TABLET in 1 BLISTER PACK6 blister pack2014-12-230000-00-00NoNoCurrent