FDA.reportPublic FDA data

Stomach Relief

Product NDC
68210-0469
Requested package NDC
68210-0469-3
11-digit product format
682100469
Labeler code
68210
Product ID
68210-0469_eea1e06c-4e41-2bdd-e053-2a95a90ab1e4
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
2019-06-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-046968210-0469-3IInactivated 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
68210-0469-3Stomach Relief1 in 1 CARTONCAPSULE, LIQUID FILLED17
68210-0469-3Stomach Relief30 in 1 BOTTLECAPSULE, LIQUID FILLED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0469STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 2 package rows20241213_d0c51e32-124b-40ce-aa50-548cc0f50d03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSNd0c51e32-124b-40ce-aa50-548cc0f50d037
2121072bismuth subsalicylate 262 MG Oral CapsuleSCDd0c51e32-124b-40ce-aa50-548cc0f50d037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0469-3682100469031 BOTTLE in 1 CARTON (68210-0469-3) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-06-280000-00-00NoNoCurrent