Stomach Relief, Maximum Strength

Product NDC
76281-558
11-digit product format
762810558
Labeler code
76281
Product ID
76281-558_22de45fb-431e-41c3-aafc-f9d8655dc60a
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
SUSPENSION
Route
ORAL
Labeler
AptaPharma Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-30
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
Stomach Relief, Maximum Strength
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
76281-558-25Stomach Relief, Maximum Strength177 mL in 1 BOTTLESUSPENSION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-558STOMACH RELIEF, MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) SUSPENSION [APTAPHARMA INC.]2Current NDC, Legacy NDC, 1 package rows20231231_cdd436f6-b769-49aa-9e6c-da512da9e6e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNcdd436f6-b769-49aa-9e6c-da512da9e6e32
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDcdd436f6-b769-49aa-9e6c-da512da9e6e32
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYcdd436f6-b769-49aa-9e6c-da512da9e6e32
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYcdd436f6-b769-49aa-9e6c-da512da9e6e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-558-2576281055825177 mL in 1 BOTTLE (76281-558-25) 177 ml2020-09-300000-00-00NoNoCurrent