FDA.reportPublic FDA data

Quality Choice Regular Strength Stomach Relief

Product NDC
83324-020
11-digit product format
833240020
Labeler code
83324
Product ID
83324-020_61aaa192-d2eb-4786-a10f-47d612643f15
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
part335
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quality Choice Regular Strength Stomach Relief
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
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
83324-020-08Quality Choice Regular Strength Stomach Relief236 mL in 1 BOTTLELIQUID2361
83324-020-12Quality Choice Regular Strength Stomach Relief354 mL in 1 BOTTLELIQUID3541

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-020-08ML - Milliliter83324-020245d4858-4e5d-4976-8312-7224146c397912026-01-08
83324-020-12ML - Milliliter83324-0201fa07d86-479d-4145-bc72-a3dc06584c5d12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-020QUALITY CHOICE REGULAR STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]1Current NDC, 2 package rows20240420_61aaa192-d2eb-4786-a10f-47d612643f15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN61aaa192-d2eb-4786-a10f-47d612643f151
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD61aaa192-d2eb-4786-a10f-47d612643f151
308762bismuth subsalicylate 1.75 % Oral SuspensionSY61aaa192-d2eb-4786-a10f-47d612643f151
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY61aaa192-d2eb-4786-a10f-47d612643f151
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY61aaa192-d2eb-4786-a10f-47d612643f151
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY61aaa192-d2eb-4786-a10f-47d612643f151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-020-0883324002008236 mL in 1 BOTTLE (83324-020-08) 236 ml2024-04-18NoNoHistorical
83324-020-1283324002012354 mL in 1 BOTTLE (83324-020-12) 354 ml2024-04-18NoNoHistorical