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 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
308763Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fc01a1a-4b1d-4c78-9955-220984a8019cAvailable on FDA.report

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

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 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach ReliefBISMUTH SUBSALICYLATEH E B7d721ce3-746f-49aa-916d-eb5a8b3578132026-08-21WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporatione8107300-921c-4ba4-ad6e-f4cf1cd5c2952026-08-20WarningsExact identifier
application number: M008
CVS Health Anti-Diarrheal VanillaBISMUTH SUBSALICYLATECVS Pharmacy,Inc.ce1ed357-228b-452c-9bd4-6b0d20f41c1d2026-08-17WarningsExact identifier
application number: M008
CVS Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECVS PHARMACYa7fb56c5-9b34-48b8-a355-a16979a0aa7b2026-08-17WarningsExact identifier
application number: M008
regular strength pink bismuthBISMUTH SUBSALICYLATECVS PHARMACY, INC.2b2a1de0-12fa-4800-91e8-f70a405eec722026-08-17WarningsExact identifier
application number: M008
CVS Health Stomach relief Cherry FlavorBISMUTH SUBSALICYLATECVS PHARMACY,INC.c0bb2b6e-8187-495e-8eac-2324fae86cf52026-08-13WarningsExact identifier
application number: M008
CVS Stomach ReliefBISMUTH SUBSALICYLATECVSeb96b2bb-7b2a-4664-96ac-73c917c84c302026-08-13WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)1af2a7dd-45d7-41a0-af61-4a588f1c19852026-08-12WarningsExact identifier
application number: M008
WinCo FOODS Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODSacf82012-0e40-4d50-b1f1-f36dc3dfad842026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS19c14efc-bf5f-4ef5-a727-aaccfae093f02026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS LLC53ae695d-f812-462d-9487-8fb5db0aa27d2026-08-07WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companybb8d2ed8-54a2-2295-e053-2995a90a10ac2026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company252b143f-eee8-f407-e063-6394a90a0a082026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d20af4fb-d579-4d1e-86ae-342933f4de752026-07-15WarningsExact identifier
application number: M008

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