FDA.reportPublic FDA data

Stomach Relief

Product NDC
21130-624
11-digit product format
211300624
Labeler code
21130
Product ID
21130-624_b797fd83-e9b6-43c2-9b78-b97767c341d1
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/30mL
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
Stomach Relief
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762

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
21130-624-08Stomach ReliefRegular Strength237 mL in 1 BOTTLE, PLASTICLIQUID2373
21130-624-12Stomach ReliefRegular Strength355 mL in 1 BOTTLE, PLASTICLIQUID3553
21130-624-16Stomach ReliefRegular Strength473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-624STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [SAFEWAY, INC.]3Current NDC, Legacy NDC, 3 package rows20240516_2bde4e41-ffbd-4d9d-ae00-e39a5c7264b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33
308762bismuth subsalicylate 1.75 % Oral SuspensionSY2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY2bde4e41-ffbd-4d9d-ae00-e39a5c7264b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-624-0821130062408237 mL in 1 BOTTLE, PLASTIC (21130-624-08) 237 ml2019-11-290000-00-00NoNoCurrent
21130-624-1221130062412355 mL in 1 BOTTLE, PLASTIC (21130-624-12) 355 ml2019-11-290000-00-00NoNoCurrent
21130-624-1621130062416473 mL in 1 BOTTLE, PLASTIC (21130-624-16) 473 ml2019-11-290000-00-00NoNoCurrent