Stomach Relief - Maximum Strength

Product NDC
76281-538
11-digit product format
762810538
Labeler code
76281
Product ID
76281-538_e1c9aa00-c943-4589-8f0b-92ec76d91897
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
LIQUID
Route
ORAL
Labeler
AptaPharma Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
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
76281-538-26Stomach Relief - Maximum Strength237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-538STOMACH RELIEF - MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [APTAPHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20231231_15cd9163-16d6-4332-9e26-77c05e0a26a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN15cd9163-16d6-4332-9e26-77c05e0a26a73
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD15cd9163-16d6-4332-9e26-77c05e0a26a73
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY15cd9163-16d6-4332-9e26-77c05e0a26a73
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY15cd9163-16d6-4332-9e26-77c05e0a26a73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-538-2676281053826237 mL in 1 BOTTLE (76281-538-26) 237 ml2018-10-010000-00-00NoNoCurrent