FDA.reportPublic FDA data

Stomach Relief

Product NDC
36800-134
Requested package NDC
36800-134-66
11-digit product format
368000134
Labeler code
36800
Product ID
36800-134_ee27fdf1-15ae-0dcc-e053-2995a90ad555
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates 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 packagepackage36800-13436800-134-66IInactivated by FDA2026-10-12

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-134-66Stomach Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14
36800-134-66Stomach Relief30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-134STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]4Legacy NDC, 2 package rows20241222_16de50a9-ec46-4afd-9766-6e2d6d1c141b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN16de50a9-ec46-4afd-9766-6e2d6d1c141b4
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD16de50a9-ec46-4afd-9766-6e2d6d1c141b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-134-66368000134661 BOTTLE in 1 CARTON (36800-134-66) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-06-280000-00-00NoNoCurrent