Stomach Relief

Product NDC
49580-0842
11-digit product format
495800842
Labeler code
49580
Product ID
49580-0842_2098abda-1027-4fc4-b273-2a0f39316a41
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-28
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
Stomach Relief
Brand name suffix
Ultra Strength
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49580-0842-82023-06-01C16284748780-1f386c649-e414-0266-e053-dadaa90a7c1aDrug Facts
49580-0842-82023-01-30C16284748780-1f386c649-e414-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0842-8Stomach ReliefUltra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0842STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 1 package rows20240418_cb5ca7ab-39cf-4b07-ac22-a00b214db102.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSNcb5ca7ab-39cf-4b07-ac22-a00b214db1023
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCDcb5ca7ab-39cf-4b07-ac22-a00b214db1023
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSYcb5ca7ab-39cf-4b07-ac22-a00b214db1023
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSYcb5ca7ab-39cf-4b07-ac22-a00b214db1023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0842-849580084208237 mL in 1 BOTTLE, PLASTIC (49580-0842-8) 237 ml2019-02-280000-00-00NoNoCurrent