FDA.reportPublic FDA data

Ultra Stomach Relief

Product NDC
21130-662
11-digit product format
211300662
Labeler code
21130
Product ID
21130-662_fc7c84ee-b7a2-47bb-9227-15e4ea248653
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Stomach Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308763

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
21130-662-08Ultra Stomach Relief237 mL in 1 BOTTLE, PLASTICLIQUID2373
21130-662-12Ultra Stomach Relief355 mL in 1 BOTTLE, PLASTICLIQUID3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-662ULTRA STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [SAFEWAY, INC.]3Current NDC, Legacy NDC, 2 package rows20240517_71ca1c0e-50dc-4970-ae0d-5f7be1eec6df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN71ca1c0e-50dc-4970-ae0d-5f7be1eec6df3
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD71ca1c0e-50dc-4970-ae0d-5f7be1eec6df3
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY71ca1c0e-50dc-4970-ae0d-5f7be1eec6df3
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY71ca1c0e-50dc-4970-ae0d-5f7be1eec6df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-662-0821130066208237 mL in 1 BOTTLE, PLASTIC (21130-662-08) 237 ml2019-11-290000-00-00NoNoCurrent
21130-662-1221130066212355 mL in 1 BOTTLE, PLASTIC (21130-662-12) 355 ml2019-11-290000-00-00NoNoCurrent