FDA.reportPublic FDA data

Bismuth Subsalicylate Pink Bismuth

Product NDC
42507-267
11-digit product format
425070267
Labeler code
42507
Product ID
42507-267_4592cb6b-f62b-4394-becd-c04856510842
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Hyvee Inc
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-23
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
Listing certified through
2027-12-31
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
Bismuth Subsalicylate Pink BismuthBISMUTH SUBSALICYLATEHyvee Inc4e575573-9ded-bfbf-e063-6394a90aed3b2026-06-23WarningsExact identifier

Warnings cross-check#

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

warnings

WARNINGS Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products 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 behaviour 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Bismuth Subsalicylate Pink Bismuth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
42507-267-77425070267775 BLISTER PACK in 1 BOX (42507-267-77) / 6 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2026-06-230Current