FDA.reportPublic FDA data

Bismutina

Product NDC
53145-475
11-digit product format
531450475
Labeler code
53145
Product ID
53145-475_3a8b33c7-04b9-345d-e063-6294a90abba9
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M024
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bismutina
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-475-082023-07-28C16284748780-10191ceaa-653d-198a-e063-dbdaa90aec3eBismutina

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-475-08Bismutina240 mL in 1 BOTTLELIQUID2403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93
308762bismuth subsalicylate 1.75 % Oral SuspensionSY14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY14bbbdbb-87c8-47a9-9147-7e0f1b75c7b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-475-0853145047508240 mL in 1 BOTTLE (53145-475-08) 240 ml2021-04-010000-00-00NoNoCurrent