Bismuth subsalicylate

Product NDC
35916-0234
11-digit product format
359160234
Labeler code
35916
Product ID
35916-0234_495a7b34-57db-3f94-e063-6394a90ad088
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-27
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
Bismuth subsalicylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui2121072

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0234-1Bismuth subsalicylate1 in 1 CARTONCAPSULE, LIQUID FILLED12
35916-0234-1Bismuth subsalicylate10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0234BISMUTH SUBSALICYLATE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]1Current NDC, 2 package rows20240528_18f59606-1498-bd0c-e063-6394a90a7df2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN18f59606-1498-bd0c-e063-6394a90a7df22
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD18f59606-1498-bd0c-e063-6394a90a7df22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-0234-1359160234011 BLISTER PACK in 1 CARTON (35916-0234-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2024-05-27NoNoCurrent