FDA.reportPublic FDA data

Stomach Relief

Product NDC
68210-4092
11-digit product format
682104092
Labeler code
68210
Product ID
68210-4092_eec90018-869f-c082-e053-2a95a90ab382
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4092IInactivated by FDA2026-10-15
excluded packagepackage68210-409268210-4092-1IInactivated by FDA2026-10-15
excluded packagepackage68210-409268210-4092-2IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

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
68210-4092-1Stomach Relief75 in 1 BOTTLECAPSULE, LIQUID FILLED755
68210-4092-2Stomach Relief25 in 1 BOTTLECAPSULE, LIQUID FILLED255
68210-4092-2Stomach Relief1 in 1 CARTONCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4092STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 3 package rows20240111_a304fddd-7d4f-4c0b-b51f-46de19733e3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSNa304fddd-7d4f-4c0b-b51f-46de19733e3d5
2121072bismuth subsalicylate 262 MG Oral CapsuleSCDa304fddd-7d4f-4c0b-b51f-46de19733e3d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4092-16821040920175 CAPSULE, LIQUID FILLED in 1 BOTTLE (68210-4092-1) 2020-07-020000-00-00NoNoCurrent
68210-4092-2682104092021 BOTTLE in 1 CARTON (68210-4092-2) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-07-020000-00-00NoNoCurrent