FDA.reportPublic FDA data

Stomach Relief

Product NDC
63868-814
Requested package NDC
63868-814-08
11-digit product format
638680814
Labeler code
63868
Product ID
63868-814_13cada8c-ab88-436a-bc1c-ef517de72ff1
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-26
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage63868-81463868-814-08DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-814-082023-05-10C16284748780-1f386c649-9b64-0266-e053-dadaa90a7c1aDrug Facts
63868-814-082023-01-30C16284748780-1f386c649-9b64-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-814STOMACH RELIEF ULTRA (BISMUTH SUBSALICYLATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC20250130_d8944d95-fa71-4362-8fcd-bf3c48b87ca5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-814-0863868081408237 mL in 1 BOTTLE, PLASTIC (63868-814-08) 237 ml2021-03-260000-00-00NoNoCurrent