Maximum Strength Stomach Relief

Product NDC
53041-528
11-digit product format
530410528
Labeler code
53041
Product ID
53041-528_af899b52-7d8c-4485-9fb8-006dae53568a
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
1050 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
Maximum Strength Stomach Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE1050 mg/30mL

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
53041-528-04Maximum Strength Stomach Relief236 mL in 1 BOTTLELIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-528MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1Current NDC, 1 package rows20250214_af899b52-7d8c-4485-9fb8-006dae53568a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNaf899b52-7d8c-4485-9fb8-006dae53568a1
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDaf899b52-7d8c-4485-9fb8-006dae53568a1
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYaf899b52-7d8c-4485-9fb8-006dae53568a1
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYaf899b52-7d8c-4485-9fb8-006dae53568a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-528-0453041052804236 mL in 1 BOTTLE (53041-528-04) 236 ml2025-02-10NoNoCurrent