FDA.reportPublic FDA data

Quality Choice Regular Strength Stomach Relief

Product NDC
83324-020
Requested package NDC
83324-020-08
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
61aaa192-d2eb-4786-a10f-47d612643f15Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.61aaa192-d2eb-4786-a10f-47d612643f152024-04-18WarningsExact identifier
ndc (package): 83324-020-08
ndc (product): 83324-020
ndc11 (package): 83324002008

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 ml2024-04-18NoNoCurrent