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 | Care One (Retail Business Services, LLC.) | eb7f3d65-8741-407d-b3f3-1d9dda19684d | 2024-03-05 | Warnings | M007 |
| Fleet | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC | C.B. Fleet Company, Inc. | f50ba829-16c3-40a7-9822-8d6d00353b33 | 2024-02-29 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 4ce62421-97e0-4920-9a6d-9fa1f0f93fe4 | 2024-02-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 851a5dda-e72b-4067-a98f-54d3222f646e | 2024-02-23 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 2ca80e23-f38a-4f77-b536-131cc9f0cf5b | 2024-02-23 | Warnings | M007 |
| Colon Detox | DOCUSATE SODIUM AND SENNOSIDES | OPMX LLC | 0a4d3265-080c-d2ed-e063-6394a90adbee | 2024-02-21 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | Best Choice (Valu Merchandisers Company) | 4501d718-15a7-4e27-bdb1-8aa2d3ff06d0 | 2024-02-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Best Choice (Valu Merchandisers Company) | 72bd251b-4e82-41ef-8362-39f95faf9916 | 2024-02-15 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON | CARDINAL HEALTH, INC. 063997360 | 10bdd5e6-3db2-8f9e-e063-6394a90a9b3f | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | CARDINAL HEALTH, INC. 063997360 | 10beb3ec-a189-221d-e063-6394a90aabb5 | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | CARDINAL HEALTH, INC. 063997360 | 10bebb63-19b3-2e14-e063-6394a90a8d4e | 2024-02-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Proficient Rx LP | f9ac0344-5864-4ac1-81bc-16878a5946c5 | 2024-02-01 | Warnings | M007 |
| Purifi Hand Sanitizer | BENZALKONIUM CHLORIDE | Purifi LLC | 9267069d-4cf5-4e48-a446-7dbebea16bf5 | 2024-01-31 | Warnings | M007 |
| WOMENS LAXATIVE ENTERIC COATED | BISACODYL | CARDINAL HEALTH | ab34bc89-6738-d284-e053-2a95a90a5dc9 | 2024-01-11 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE | SENNOSIDES | CARDINAL HEALTH | b7b13bfa-8a94-6f62-e053-2995a90abbf4 | 2024-01-10 | Warnings | M007 |
| FIBER LAXATIVE | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | e4a921c5-1cf7-12ca-e053-2a95a90a6e04 | 2024-01-03 | Warnings | M007 |
| Freskaro Castor Oil | CASTOR OIL | Pharma Nobis, LLC | fbd6bdd5-a7a1-3f28-e053-6294a90aab87 | 2023-12-28 | Warnings | M007 |
| Humco Castor Oil | CASTOR OIL | Pharma Nobis, LLC | e42f9d37-1b07-177a-e053-2a95a90a9b06 | 2023-12-26 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Pharma Nobis, LLC | f0477328-eca1-9043-e053-2995a90aaa3d | 2023-12-22 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Pharma Nobis, LLC | f0489f6f-9e60-7d69-e053-2a95a90a9dfb | 2023-12-22 | 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 |