Calcium Polycarbophil
- Product NDC
- 58624-5003
- 11-digit product format
- 586245003
- Labeler code
- 58624
- Product ID
- 58624-5003_e7768a51-609b-4d3e-9864-b94ee9ccbdd9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calcium Polycarbophil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-04-12
- 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 |
|---|---|
| CALCIUM POLYCARBOPHIL | 625 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8F049NKY49 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308934 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ee06868b-f741-8da2-e053-2a95a90a9772 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58624-5003-1 | Calcium Polycarbophil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58624-5003 | CALCIUM POLYCARBOPHIL TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.] | 7 | Current NDC, 1 package rows | 20250110_ee06868b-f741-8da2-e053-2a95a90a9772.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Curewell Senna Syrup | SENNOSIDES | RMT HEALTH LLC | 57345324-5140-5cde-e063-6294a90ab97c | 2026-07-22 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE ORAL SOLUTION | WALGREEN COMPANY | 4ffe54ae-3126-ba58-e063-6294a90a8877 | 2026-07-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | deca083b-5c72-40fa-9021-b74028426a5a | 2026-07-20 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | fc5e82b6-e25c-4686-9781-2205819685f5 | 2026-07-20 | Warnings | M007 |
| Best Choice Fiber Therapy Orange Flavor | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 0b25f6c0-441b-41ef-ab19-2a29705a56c6 | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Therapy original coarse | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d7eb71af-17e3-465e-b464-f77b3be7266d | 2026-07-17 | Warnings | M007 |
| Best Choice | CALCIUM POLYCARBOPHIL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 24eb538f-abcb-4a91-b691-a8aac01c952a | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Laxative | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 92b46689-b5fc-41f4-91ac-535699900b39 | 2026-07-17 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 498acb19-b2f4-4af0-8996-390115c17fe0 | 2026-07-17 | Warnings, Adverse reactions | M007 |
| Best Choice Fiber Therapy | METHYLCELLULOSE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | fab6567f-d988-43f2-a6cf-44e5b24af279 | 2026-07-17 | Warnings | M007 |
| stool softener | DOCUSATE SODIUM | Amazon.com Services LLC | 4f83953e-3779-43b7-a5c6-7442a0675d9b | 2026-07-16 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 183576bd-c252-471b-8797-32cac5b0329c | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Walgreens | 3f9d54d9-a9d5-40ff-a8a2-431997b58999 | 2026-07-16 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 7174021b-bdc0-4fd3-90e7-3904980033c4 | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | ff2179bd-cc76-9ee9-e053-6294a90a01c9 | 2026-07-15 | Warnings | M007 |
| FEVIA Constipation Control | DOCUSATE SODIUM | VIVUNT PHARMA LLC | 4b21ca11-b81f-402c-e063-6394a90a3acb | 2026-07-15 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | 56957a51-7366-f7ed-e063-6294a90abfc5 | 2026-07-14 | Warnings | M007 |
| Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6103fded-622c-4551-9f32-ca1da44683ac | 2026-07-10 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | 800fa966-077d-4624-9e36-75fe8863dad0 | 2026-07-10 | Warnings | M007 |
| SENNA TIME | SENNOSIDES | Bryant Ranch Prepack | bdcf37fc-3938-4d3f-b669-35c6939eac4f | 2026-07-10 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308934 | calcium polycarbophil 625 MG Oral Tablet | PSN | ee06868b-f741-8da2-e053-2a95a90a9772 | 7 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | SCD | ee06868b-f741-8da2-e053-2a95a90a9772 | 7 |
| 308934 | calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet | SY | ee06868b-f741-8da2-e053-2a95a90a9772 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 58624-5003-1 | 58624500301 | 90 TABLET, FILM COATED in 1 BOTTLE (58624-5003-1) | 2023-04-12 | No | No | Current |