Major Bismuth Subsalicylate

Product NDC
68788-8239
11-digit product format
687888239
Labeler code
68788
Product ID
68788-8239_6ad4aa56-96a5-413c-8abd-dec8ead6bb1a
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-11
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8239-3Major Bismuth Subsalicylate6 in 1 BLISTER PACKTABLET, CHEWABLE64
68788-8239-3Major Bismuth Subsalicylate5 in 1 BOXTABLET, CHEWABLE54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8239MAJOR BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250210_69b9999f-c2e5-43a6-891f-0e24d3c343a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN69b9999f-c2e5-43a6-891f-0e24d3c343a44
308761bismuth subsalicylate 262 MG Chewable TabletSCD69b9999f-c2e5-43a6-891f-0e24d3c343a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8239-3687888239035 BLISTER PACK in 1 BOX (68788-8239-3) / 6 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2025-02-07NoNoHistorical