FDA.reportPublic FDA data

Ultra Bismuth

Product NDC
55910-637
11-digit product format
559100637
Labeler code
55910
Product ID
55910-637_c751324d-47d9-49f0-b941-a526747e71c3
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
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
Ultra Bismuth
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
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
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
55910-637-04Ultra Bismuth118 mL in 1 BOTTLE, PLASTICLIQUID1185
55910-637-12Ultra Bismuth355 mL in 1 BOTTLE, PLASTICLIQUID3555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-637ULTRA BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]5Current NDC, Legacy NDC, 2 package rows20240831_0fc01a1a-4b1d-4c78-9955-220984a8019c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN0fc01a1a-4b1d-4c78-9955-220984a8019c5
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD0fc01a1a-4b1d-4c78-9955-220984a8019c5
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY0fc01a1a-4b1d-4c78-9955-220984a8019c5
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY0fc01a1a-4b1d-4c78-9955-220984a8019c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-637-0455910063704118 mL in 1 BOTTLE, PLASTIC (55910-637-04) 118 ml2019-11-290000-00-00NoNoCurrent
55910-637-1255910063712355 mL in 1 BOTTLE, PLASTIC (55910-637-12) 355 ml2019-11-290000-00-00NoNoCurrent