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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYNTHABIO IvermectinIVERMECTINShenzhen Xuyan Technology Co., Ltd.540d6a24-68bf-50c8-e063-6294a90aaa302026-06-22WarningsExact identifier
application number: M024
PINRIDPYRANTEL PAMOATEYYBA CORP59da86a4-db0d-4551-9128-e09a4e85cd782026-05-25WarningsExact identifier
application number: M024
PINRIDPYRANTEL PAMOATEYYBA CORP52a9b5c8-08e6-b91e-e063-6294a90a0e0d2026-05-25WarningsExact identifier
application number: M024
PREPAKU FENBENDAZOLE Canine DewormerFENBENDAZOLEShenzhen Zhenshangzekai Technology Co., Ltd.4d722051-6a49-75ea-e063-6294a90a7b4e2026-03-20WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATEBIONPHARMA INC.3cf96d04-e8bc-31af-e063-6294a90a0db82026-01-23WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATEAMERISOURCE BERGEN4837905f-1037-a319-e063-6294a90aba042026-01-21WarningsExact identifier
application number: M024
Pyrantel PamoatePYRANTEL PAMOATEJefferson Labse862b337-2991-4b56-8584-fd80dccd725f2025-12-19WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATESTRATEGIC SOURCING SERVICES453c0645-f2b4-aa4a-e063-6294a90af1fb2025-12-05WarningsExact identifier
application number: M024
LombrixPYRANTEL PAMOATEOPMX LLC3f940481-8e75-0bc7-e063-6394a90af1cd2025-09-24WarningsExact identifier
application number: M024
PARASITOLPYRANTEL PAMOATEMenper Distributors Inc.cd5eb4c9-d0f0-4be7-84eb-88ebc4632dc62025-07-22WarningsExact identifier
application number: M024
BismutinaBISMUTH SUBSALICYLATEMenper Distributors, Inc.14bbbdbb-87c8-47a9-9147-7e0f1b75c7b92025-07-22WarningsExact identifier
application number: M024
ndc (product): 53145-475
PINRIDPYRANTEL PAMOATEYYBA CORPfc225b5b-0ce8-4394-a643-39dbc674d7cd2025-07-02WarningsExact identifier
application number: M024
MebendamaX PinwormPYRANTEL PAMOATEPharmadel LLC1d75b912-3550-7d4c-e063-6294a90ad5fa2025-06-18WarningsExact identifier
application number: M024
Pyrantel PamoatePYRANTEL PAMOATEProMex LLCe68c503a-6f79-4f83-a6f3-c12a13fb06a02024-12-18WarningsExact identifier
application number: M024
Pinworm MedicinePYRANTEL PAMOATEREESE PHARMACEUTICAL CO.f23d5092-48ca-46c4-830a-c34d0a3a7f572024-12-18WarningsExact identifier
application number: M024
Walgreens Pinworm MedicinePYRANTEL PAMOATEWalgreens7fd58448-6846-4d8e-994c-d0ca2fd38e682024-12-18WarningsExact identifier
application number: M024
CVS Pinworm TreatmentPYRANTEL PAMOATECVS PHARMACY INCd079008a-c87a-45f2-8775-0e40241761f02024-12-18WarningsExact identifier
application number: M024
VRMX 500PYRANTEL PAMOATEOPMX LLCe119cad8-9814-7d5a-e053-2995a90afde52024-02-06WarningsExact identifier
application number: M024

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