Stomach Relief

Product NDC
55319-560
11-digit product format
553190560
Labeler code
55319
Product ID
55319-560_d99aa65c-fa47-48c6-9005-060d983a8666
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)d28ef2ae-2b0a-4f32-9bc1-6803806f3c812025-11-11WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood) When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Stomach Relief
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
55319-560-08Stomach Relief237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-560STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 1 package rows20240328_d28ef2ae-2b0a-4f32-9bc1-6803806f3c81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNd28ef2ae-2b0a-4f32-9bc1-6803806f3c816
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDd28ef2ae-2b0a-4f32-9bc1-6803806f3c816
308762bismuth subsalicylate 1.75 % Oral SuspensionSYd28ef2ae-2b0a-4f32-9bc1-6803806f3c816
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYd28ef2ae-2b0a-4f32-9bc1-6803806f3c816
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYd28ef2ae-2b0a-4f32-9bc1-6803806f3c816
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYd28ef2ae-2b0a-4f32-9bc1-6803806f3c816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-560-0855319056008237 mL in 1 BOTTLE, PLASTIC (55319-560-08) 237 ml2023-07-01NoNoCurrent