FDA.reportPublic FDA data

Stomach Relief

Product NDC
63868-813
Requested package NDC
63868-813-08
11-digit product format
638680813
Labeler code
63868
Product ID
63868-813_506e481f-23df-4a23-ae42-7a6c9425a7b6
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
2021-06-25
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 packagepackage63868-81363868-813-08DDiscontinued by firm2026-10-05

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
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-813-08Stomach ReliefUltra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-813-08ML - Milliliter63868-8132d4bcb5c-25de-461d-ad30-01a6e5a448bd12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-813STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC, 1 package rows20241102_b8bcdbb3-9210-4bf6-9ef2-1ed8e3ec255d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNb8bcdbb3-9210-4bf6-9ef2-1ed8e3ec255d3
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDb8bcdbb3-9210-4bf6-9ef2-1ed8e3ec255d3
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYb8bcdbb3-9210-4bf6-9ef2-1ed8e3ec255d3
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYb8bcdbb3-9210-4bf6-9ef2-1ed8e3ec255d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-813-0863868081308237 mL in 1 BOTTLE, PLASTIC (63868-813-08) 237 ml2021-06-250000-00-00NoNoCurrent