Fiber Lax
- Product NDC
- 0536-4306
- 11-digit product format
- 005364306
- Labeler code
- 0536
- Product ID
- 0536-4306_44fe10f1-66d5-9187-e063-6294a90a4d7f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calcium Polycarbophil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-09-01
- 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
- Fiber Lax
- 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 |
|---|---|
| 318d81ed-0b06-4d21-8b97-2d1f0267c781 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0536-4306-05 | Fiber Lax | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 8 | |
| 0536-4306-08 | Fiber Lax | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 8 | |
| 0536-4306-08 | Fiber Lax | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 8 | |
| 0536-4306-11 | Fiber Lax | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-4306-05 | EA - Each | 0536-4306 | 463c1279-6853-4f79-912a-8572fd9cc5cb | 1 | 2012-07-24 |
| 0536-4306-08 | EA - Each | 0536-4306 | 0195b521-a1e1-41ec-8d0b-23b27de41bb1 | 1 | 2012-07-24 |
| 0536-4306-11 | EA - Each | 0536-4306 | 8919242e-6c8d-4c4a-83bc-af8ed23ccb96 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pure and Gentle Laxative | SODIUM PHOSPHATE | Medline Industries, LP | e3165538-75dd-4f0f-adc8-d4075de10f1e | 2024-11-26 | Warnings | M007 |
| DOCUSATE SODIUM 50 MG | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 7cf1df18-d658-4bff-8a62-365fc5656942 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | c5bdfbfc-d24a-4088-9b60-ecea8120ff43 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b10fdf50-289e-41f3-9b83-a4e4dd892f88 | 2024-11-21 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 85c64624-428d-46fa-8071-f42b8feec049 | 2024-11-21 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0 | 2024-11-21 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Walgreen Co. | d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5 | 2024-11-21 | Warnings | M007 |
| 4718 Enema, Mineral Oil | 4718 ENEMA, MINERAL OIL | Dynarex | 9e51c852-9477-5cf5-e053-2a95a90a97db | 2024-11-20 | Warnings | M007 |
| Relief | SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | Leosons Overseas Corp | 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940 | 2024-11-19 | Warnings | M007 |
| REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Leosons Overseas Corp | 90e7c2b4-35e1-4a27-afea-9257c480e190 | 2024-11-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM 100MG | PuraCap Pharmaceutical LLC | 272c86f1-f229-2ebf-e063-6394a90a3471 | 2024-11-18 | Warnings | M007 |
| Milk of Magnesia Concentrate | MAGNESIUM HYDROXIDE | PAI Holdings, LLC dba PAI Pharma | 2a99a1a8-a830-429f-9cfd-3f29c3d3547c | 2024-11-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 122486e9-74dd-4181-97d1-0b07688280f4 | 2024-11-06 | Warnings | M007 |
| Stratuscare Adult Glycerin | GLYCERIN | Stratus Pharmaceuticals | 3e1935da-5c1f-4942-98dd-320fade82321 | 2024-11-04 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | fdf3c8e1-d554-4cdb-e053-6394a90a542e | 2024-11-01 | Warnings | M007 |
| Stratuscare Glycerin Laxative Pediatric | GLYCERIN | Stratus Pharmaceuticals | 6ae6d3c4-bb3b-4436-b76d-8654bf871e66 | 2024-11-01 | Warnings | M007 |
| Rite Aid Fiber Therapy | METHYLCELLULOSE | RITE AID CORPORATION | e50cea80-c020-4b85-b61f-d053f11f479b | 2024-10-30 | Warnings | M007 |
| Rite Aid Fiber Caplets | CALCIUM POLYCARBOPHIL | RITE AID CORPORATION | 06e46cb0-2928-479e-984d-2305fff995e0 | 2024-10-30 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308934 | calcium polycarbophil 625 MG Oral Tablet | PSN | 730198a5-b6d9-4fc7-b053-a7c65a93c540 | 10 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | SCD | 730198a5-b6d9-4fc7-b053-a7c65a93c540 | 10 |
| 308934 | calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet | SY | 730198a5-b6d9-4fc7-b053-a7c65a93c540 | 10 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | PSN | 318d81ed-0b06-4d21-8b97-2d1f0267c781 | 8 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | SCD | 318d81ed-0b06-4d21-8b97-2d1f0267c781 | 8 |
| 308934 | calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet | SY | 318d81ed-0b06-4d21-8b97-2d1f0267c781 | 8 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | PSN | e1e31142-4256-4b12-8d2b-29a6cf45dc91 | 1 |
| 308934 | calcium polycarbophil 625 MG Oral Tablet | SCD | e1e31142-4256-4b12-8d2b-29a6cf45dc91 | 1 |
| 308934 | calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet | SY | e1e31142-4256-4b12-8d2b-29a6cf45dc91 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0536-4306-05 | 00536430605 | 500 TABLET, FILM COATED in 1 BOTTLE (0536-4306-05) | 2010-09-01 | 0000-00-00 | No | No | Current | |
| 0536-4306-08 | 00536430608 | 2 BLISTER PACK in 1 CARTON (0536-4306-08) / 30 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2010-09-01 | 0000-00-00 | No | No | Current |
| 0536-4306-11 | 00536430611 | 90 TABLET, FILM COATED in 1 BOTTLE (0536-4306-11) | 2010-09-01 | 0000-00-00 | No | No | Current |