FDA.reportPublic FDA data

Stomach Relief

Product NDC
63868-691
11-digit product format
638680691
Labeler code
63868
Product ID
63868-691_2ce9d01e-aefe-46fd-a6bc-7321dc8c6c2d
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-691DDiscontinued by firm2026-10-05
excluded packagepackage63868-69163868-691-40DDiscontinued 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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-691-40Stomach Relief40 in 1 BOTTLE, PLASTICTABLET406
63868-691-40Stomach Relief1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-691-40EA - Each63868-6912c1a41e0-f2c2-48fb-80ca-27e325a6616b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-691STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]5Legacy NDC, 2 package rows20241023_e1552f01-ab98-41c7-a7be-aedf2d40e437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSNe1552f01-ab98-41c7-a7be-aedf2d40e4376
308760bismuth subsalicylate 262 MG Oral TabletSCDe1552f01-ab98-41c7-a7be-aedf2d40e4376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-691-40638680691401 BOTTLE, PLASTIC in 1 CARTON (63868-691-40) > 40 TABLET in 1 BOTTLE, PLASTIC2021-03-310000-00-00NoNoCurrent