Calcium Polycarbophil

Product NDC
70000-0067
11-digit product format
700000067
Labeler code
70000
Product ID
70000-0067_42f2e803-8cbd-dd94-e063-6294a90a0cd0
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-18
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
Calcium Polycarbophil
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
b4637e18-c65f-0e81-e053-2a95a90a2284Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0067-1Calcium Polycarbophil250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0067-1EA - Each70000-0067df485456-7dc5-4dce-9775-0f0478a0f77b12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0067CALCIUM POLYCARBOPHIL TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.]5Current NDC, Legacy NDC, 1 package rows20250212_b4637e18-c65f-0e81-e053-2a95a90a2284.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 31 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC93158bd3-c830-4b12-ab1c-133a4bdb9c782024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E Bafc54b8e-03d9-418c-9322-97d68f9290312024-12-18WarningsExact identifier
application number: M007
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC59a26a7f-516f-4507-8dec-f40cf6cfaffc2024-12-17WarningsExact identifier
application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack7d1f092e-0e5b-4fed-a095-64449751582d2024-12-16WarningsExact identifier
application number: M007
Drug Mart Vegetable Laxative plus Stool SoftenerDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inc1b6d59e8-112f-447f-b6e9-526b7d3bd01e2024-12-13WarningsExact identifier
application number: M007
Drug Mart Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inccaf74258-922c-4b69-9bd6-57b3e918c7a62024-12-13WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
application number: M007
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
application number: M007
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
application number: M007
Careone Milk of magnesia Original Milk of Magnesia OriginalMAGNESIUM HYDROXIDERetail Business Services, LLC.13ffb00b-7c6f-47aa-bc82-2402d121a7582024-12-11WarningsExact identifier
application number: M007
CareOne Milk of Magnesia CherryMAGNESIUM HYDROXIDERetail Business Services, LLC.1822f90d-f693-48d7-b338-a3f2ddfac4df2024-12-11WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGOOD SENSEa951b6d0-9182-e1bc-e053-2a95a90a12b12024-12-09WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMajor Pharmaceuticalsdf3b431b-a1ad-91dd-e053-2995a90aa02f2024-12-06WarningsExact identifier
application number: M007
milk of magnesiaMAGNESIUM HYDROXIDECVS Pharmacyb3a36251-edd6-4201-8da1-85d7a6ede1732024-12-05WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
application number: M007
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd2024-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSNb4637e18-c65f-0e81-e053-2a95a90a22846
308934calcium polycarbophil 625 MG Oral TabletSCDb4637e18-c65f-0e81-e053-2a95a90a22846
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYb4637e18-c65f-0e81-e053-2a95a90a22846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0067-170000006701250 TABLET, FILM COATED in 1 BOTTLE (70000-0067-1) 2020-11-180000-00-00NoNoCurrent