FDA.reportPublic FDA data

Stomach Relief - Regular Strength

Product NDC
76281-537
11-digit product format
762810537
Labeler code
76281
Product ID
76281-537_0e43e21f-d421-4a57-9056-85b2f73aadd8
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
525 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 - Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762

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
76281-537-25Stomach Relief - Regular Strength177 mL in 1 BOTTLELIQUID1775
76281-537-28Stomach Relief - Regular Strength354 mL in 1 BOTTLELIQUID3545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-537STOMACH RELIEF - REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [APTAPHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20231231_970b4118-2c2e-4806-8fe8-937ba06cf6e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN970b4118-2c2e-4806-8fe8-937ba06cf6e95
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD970b4118-2c2e-4806-8fe8-937ba06cf6e95
308762bismuth subsalicylate 1.75 % Oral SuspensionSY970b4118-2c2e-4806-8fe8-937ba06cf6e95
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY970b4118-2c2e-4806-8fe8-937ba06cf6e95
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY970b4118-2c2e-4806-8fe8-937ba06cf6e95
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY970b4118-2c2e-4806-8fe8-937ba06cf6e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-537-2576281053725177 mL in 1 BOTTLE (76281-537-25) 177 ml2018-10-010000-00-00NoNoCurrent
76281-537-2876281053728354 mL in 1 BOTTLE (76281-537-28) 354 ml2018-10-010000-00-00NoNoCurrent