Ultra Strength Stomach Relief

Product NDC
53041-529
11-digit product format
530410529
Labeler code
53041
Product ID
53041-529_1de872f9-cb40-4614-a064-bd865e8bcab4
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Strength Stomach Relief
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
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
53041-529-04Ultra Strength Stomach Relief236 mL in 1 BOTTLELIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-529ULTRA STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]2Current NDC, 1 package rows20250312_25175eac-d15f-ce0d-e063-6394a90a0650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN25175eac-d15f-ce0d-e063-6394a90a06502
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD25175eac-d15f-ce0d-e063-6394a90a06502
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY25175eac-d15f-ce0d-e063-6394a90a06502
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY25175eac-d15f-ce0d-e063-6394a90a06502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-529-0453041052904236 mL in 1 BOTTLE (53041-529-04) 236 ml2025-02-10NoNoCurrent