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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 89106733-69f1-469b-9d07-f06ac09b2fb6 | 2024-04-02 | Warnings | M007 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | e0b7acab-add4-4daf-b1df-bb7cf5ca8e19 | 2024-04-01 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 89dc2063-6744-4412-89be-90990090b57c | 2024-03-19 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2322765d-6f08-48d4-a500-818a8a558f6f | 2024-03-19 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | dcab26ff-2c10-4478-90a8-c89d87261bfa | 2024-03-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4d1391da-7874-4a51-a468-2843ecf6f92b | 2024-03-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | adaea845-e029-422d-a947-d8ce8f5787ed | 2024-03-18 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8b033d56-b95b-4905-9f33-cf2fbd61ce35 | 2024-03-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | CVS Pharmacy | 6a97a181-1ec2-473d-a588-db2f2f2f662d | 2024-03-14 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | CVS Pharmacy | dcd27653-4c81-4630-a8b7-5fb5dc3e976a | 2024-03-13 | Warnings | M007 |
| EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE | SENNOSIDES | Haleon US Holdings LLC | 62544c2f-6e30-4cec-ae63-233715ef0699 | 2024-03-13 | Warnings | M007 |
| Laxative Stool Softener | DOCUSATE SODIUM, SENNOSIDES | CVS Pharmacy | b52181e3-fd84-479e-8590-18619f6c0dae | 2024-03-13 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | CVS Pharmacy | 5eb047d2-8317-4de3-9268-d206ca039e3d | 2024-03-13 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | f77c65b0-3e13-48ce-a2d9-36a9eba1851f | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | 849b057a-dc46-423c-a2f4-b01f135a3803 | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE CALCIUM | CVS Pharmacy | cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | 8d59fa14-fc7c-4146-ba59-c2a907356dd6 | 2024-03-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Costco Wholesale | a19c20bd-84ff-4931-8312-2fbf0400e8e0 | 2024-03-06 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | a1ea0993-2d23-44e3-bc72-e4bf497ab723 | 2024-03-05 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Care One (Retail Business Services, LLC.) | a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f | 2024-03-05 | 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 |