FDA.reportPublic FDA data

Pink Bismuth Original

Product NDC
53943-529
11-digit product format
539430529
Labeler code
53943
Product ID
53943-529_ff7a1308-d2e1-4ab4-912c-3ab4ebc5e07d
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate 525 mg
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart, Inc
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-26
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pink Bismuth Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e0cb7d7-4c4f-824a-e063-6394a90aa3a4Available on FDA.report

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
53943-529-06Pink Bismuth Original473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-529PINK BISMUTH ORIGINAL (BISMUTH SUBSALICYLATE 525 MG) LIQUID [DISCOUNT DRUG MART, INC]2Current NDC, 1 package rows20250302_2e0cb7d7-4c4f-824a-e063-6394a90aa3a4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Stomach ReliefBISMUTH SUBSALICYLATEWALGREENS CO.53fdceb2-68ea-42b9-87eb-f202e96eb5242025-11-25WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN CO.73231515-840f-4086-86da-4b815d664c132025-11-25WarningsExact identifier
application number: M008
Percy MedicineBISMUTH SUBSALICYLATEMerrick Medicine Company, Inc08dd53b7-8345-4849-9155-60429cbe2c512025-11-11WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)d28ef2ae-2b0a-4f32-9bc1-6803806f3c812025-11-11WarningsExact identifier
application number: M008
TopCare Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLC2619720a-d926-4b17-899c-54d49c78802c2025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCb93a0b38-eb5f-47c0-8112-75505e46f7c32025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCe745e693-9e45-43b0-b26c-99ca891b74b02025-11-10WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)6298b856-90ea-4054-bda3-70f92b14611d2025-11-10WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)61309786-96ee-4d9b-8dd3-8e4a91ebe88c2025-11-07WarningsExact identifier
application number: M008
up and up digestive reliefBISMUTH SUBSALICYLATETarget Corporation5731025d-ffaa-4b31-971f-e58b921e40ed2025-11-05WarningsExact identifier
application number: M008
ULTRA STRENGHT PINK BISMUTHBISMUTH SUBSALICYLATETARGET CORPORATION20063215-f657-487b-9530-6df0181b440a2025-11-05WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation7f6b2960-943d-464c-9ff9-4649a8ab4a4e2025-11-04WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation6462e224-5ee7-4556-90f2-994eaf89b71b2025-11-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
application number: M008
Digestive ReliefBISMUTH SUBSALICYLATESAFEWAY5538d56a-b258-4260-b51b-f5131bd768852025-10-29WarningsExact identifier
application number: M008
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
application number: M008
PUBLIX Regular Strength Pink BismuthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INCa9b2da55-5171-4702-9808-5b937182da022025-10-28WarningsExact identifier
application number: M008
PUBLIX Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INC4be86e84-fddf-4eb5-a519-64009d0e69fc2025-10-28WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEASCLEMED USA INC.01b318d2-586d-4953-8f98-addc4e3cd4412025-10-15WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2e0cb7d7-4c4f-824a-e063-6394a90aa3a42
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2e0cb7d7-4c4f-824a-e063-6394a90aa3a42
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2e0cb7d7-4c4f-824a-e063-6394a90aa3a42
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2e0cb7d7-4c4f-824a-e063-6394a90aa3a42
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2e0cb7d7-4c4f-824a-e063-6394a90aa3a42
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2e0cb7d7-4c4f-824a-e063-6394a90aa3a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-529-0653943052906473 mL in 1 BOTTLE (53943-529-06) 473 ml2025-02-26NoNoCurrent