FDA.reportPublic FDA data

Stomach Relief

Product NDC
62011-0435
11-digit product format
620110435
Labeler code
62011
Product ID
62011-0435_5e0db8ff-2ff9-43dd-9bdb-6b66242be823
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-30
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0435DDiscontinued by firm2026-10-05
excluded packagepackage62011-043562011-0435-1DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0435-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0435-1367a005e9d99…383a685ebd0f…

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
62011-0435-1Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0435STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC, 1 package rows20241211_dcc7c526-bbca-4e1c-b451-eb74b6687b9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNdcc7c526-bbca-4e1c-b451-eb74b6687b9c5
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDdcc7c526-bbca-4e1c-b451-eb74b6687b9c5
308762bismuth subsalicylate 1.75 % Oral SuspensionSYdcc7c526-bbca-4e1c-b451-eb74b6687b9c5
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYdcc7c526-bbca-4e1c-b451-eb74b6687b9c5
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYdcc7c526-bbca-4e1c-b451-eb74b6687b9c5
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYdcc7c526-bbca-4e1c-b451-eb74b6687b9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0435-162011043501237 mL in 1 BOTTLE, PLASTIC (62011-0435-1) 237 ml2019-10-300000-00-00NoNoCurrent