FDA.reportPublic FDA data

Premier Value

Product NDC
68016-220
11-digit product format
680160220
Labeler code
68016
Product ID
68016-220_4750bfce-9afe-4bc0-b533-a2a30f263255
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PHARMACY VALUE ALLIANCE, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-16
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Premier Value
Listing expiration
2027-12-31

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
4d766548-00d0-41bd-bb58-b69e037c77e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-220-25Premier Value250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-220PREMIER VALUE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_4d766548-00d0-41bd-bb58-b69e037c77e2.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 21 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fiber Therapy Sugar FreePSYLLIUM HUSKPUBLIX SUPER MARKETS, INCed3dc80a-a243-4013-9886-b148e3e3b6622025-10-28WarningsExact identifier
application number: M007
Childrens Oral Saline LaxativeMAGNESIUM HYDROXIDEWAL-MART STORES,INC.,a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc2025-10-27WarningsExact identifier
application number: M007
equate Fiber TherapyMETHYLCELLULOSEWal-Mart Stores,Inc.,7acc30b4-e946-42cd-8eec-cf15159d478d2025-10-27WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCVS Pharmacyc56e010a-7503-3e1c-e053-2a95a90a2b852025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLMajor Pharmaceuticalsc194c40c-c732-2f03-e053-2a95a90a7a402025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLPharmacy Value Alliance LLC8a6d6729-f6eb-4f68-e053-2a95a90a5c9e2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCardinal Healthc2b33e78-6ab7-1785-e053-2995a90a9c4f2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN4d766548-00d0-41bd-bb58-b69e037c77e26
308934calcium polycarbophil 625 MG Oral TabletSCD4d766548-00d0-41bd-bb58-b69e037c77e26
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY4d766548-00d0-41bd-bb58-b69e037c77e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-220-2568016022025250 TABLET, FILM COATED in 1 BOTTLE (68016-220-25) 2019-04-160000-00-00NoNoCurrent