FDA.reportPublic FDA data

Bismuth

Product NDC
69168-046
11-digit product format
691680046
Labeler code
69168
Product ID
69168-046_3160c469-0445-4227-8ab2-93032e0443d9
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bismuth
Listing expiration
2027-12-31

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
69168-046-32Bismuth100 in 1 BOTTLETABLET1008
69168-046-50Bismuth50 in 1 BOTTLETABLET508
69168-046-69Bismuth12 in 1 CELLO PACKTABLET128
69168-046-88Bismuth30 in 1 CELLO PACKTABLET308
69168-046-98Bismuth200 in 1 BOTTLETABLET2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-046BISMUTH (BISMUTH SUBSALICYLATE) TABLET [ALLEGIANT HEALTH]7Current NDC, Legacy NDC, 5 package rows20231107_015ca07a-f6b5-4741-a7b0-821cf6d4e418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN015ca07a-f6b5-4741-a7b0-821cf6d4e4188
308761bismuth subsalicylate 262 MG Chewable TabletSCD015ca07a-f6b5-4741-a7b0-821cf6d4e4188

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-046-3269168004632100 TABLET in 1 BOTTLE (69168-046-32) 100 tablet2023-05-31NoNoCurrent
69168-046-506916800465050 TABLET in 1 BOTTLE (69168-046-50) 50 tablet2023-11-06NoNoCurrent
69168-046-696916800466912 TABLET in 1 CELLO PACK (69168-046-69) 12 tablet2014-12-230000-00-00NoNoCurrent
69168-046-886916800468830 TABLET in 1 CELLO PACK (69168-046-88) 30 tablet2014-12-230000-00-00NoNoCurrent
69168-046-9869168004698200 TABLET in 1 BOTTLE (69168-046-98) 200 tablet2026-05-07NoNoCurrent