FDA.reportPublic FDA data

Stomach Relief

Product NDC
0536-1286
11-digit product format
005361286
Labeler code
0536
Product ID
0536-1286_dea67064-2709-4487-8517-59239f8f9edc
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
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
Brand name suffix
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
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
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
0536-1286-36Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1286STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20240829_6166c04e-20c6-4678-b16d-517474445698.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 1.75 % Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY5c02d0ba-91e4-4bd2-ac66-6905323653b25
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 1.75 % Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY6166c04e-20c6-4678-b16d-5174744456984
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 1.75 % Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY401f8393-680c-e1a8-e063-6394a90a81ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1286-3600536128636237 mL in 1 BOTTLE, PLASTIC (0536-1286-36) 237 ml2020-03-290000-00-00NoNoCurrent