FDA.reportPublic FDA data

Quality Choice

Product NDC
83324-276
11-digit product format
833240276
Labeler code
83324
Product ID
83324-276_39825b7a-6cae-ddd7-e063-6394a90a3972
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
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
Brand name suffix
Fiber Caplets
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM POLYCARBOPHIL625 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8F049NKY49Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29dbc831-23c1-487d-902a-9404d9ebe805Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-276-14Quality ChoiceFiber Caplets140 in 1 BOTTLETABLET, FILM COATED1402
83324-276-90Quality ChoiceFiber Caplets90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-276-90EA - Each83324-276be312020-8940-4d5a-8298-3598bf2ed29712025-08-11

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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMONWalmart Inc.484d0421-59ea-3783-e063-6394a90af6332026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRYWalmart Inc.484c2586-9e6f-1ce5-e063-6394a90a0d812026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPEWalmart Inc.450ddcbd-7ccd-3670-e063-6294a90ac2bd2026-03-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEAmazon.com Services LLC787ec4b0-c6c5-44ab-a53d-d6d25304f95e2026-03-03Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.3d0d63d7-640d-4e54-a6fd-6b265c79be092026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.9b3b6cea-ab83-4b7c-a425-fd0ac7df426c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.51ed515b-cc51-4ea1-b612-0904761350052026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEOld East Main Co.a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f52026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association629c5817-13b7-4527-8998-93131ee3529e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association4df97cdc-e7a2-4350-8f95-a679cdcaff642026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association46b26b44-e065-4337-a071-fa036f8971402026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Associationef163b24-ce92-4cbc-b45a-4fae3b5119492026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Marketing Association4ee26633-8eb1-4c68-a768-20460404533a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.2bcab227-42b6-4bff-8363-f6800665755b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.a87dceb2-da73-4d3a-b87c-db2af10471bf2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Kroger Co.3ae7e275-7bbc-4e62-b30f-013c40a899492026-02-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCVS Pharmacy, Inc0b7736df-c7de-7d00-e063-6294a90aa57e2026-02-26WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN29dbc831-23c1-487d-902a-9404d9ebe8052
308934calcium polycarbophil 625 MG Oral TabletSCD29dbc831-23c1-487d-902a-9404d9ebe8052
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY29dbc831-23c1-487d-902a-9404d9ebe8052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-276-1483324027614140 TABLET, FILM COATED in 1 BOTTLE (83324-276-14) 2025-06-02NoNoCurrent
83324-276-908332402769090 TABLET, FILM COATED in 1 BOTTLE (83324-276-90) 2025-06-02NoNoCurrent