Fiber Laxative

Product NDC: 36800-465
11-digit product format: 368000465
Labeler code: 36800
Product ID: 36800-465_821bab17-7641-48eb-b46f-d23c98d30a2d
Type: HUMAN OTC DRUG
Nonproprietary name: Calcium polycarbophil
Dosage form: TABLET
Route: ORAL
Labeler: Topco Associates, LLC
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-08-01
Substance: CALCIUM POLYCARBOPHIL
Active strength: 625 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-465-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-465-27	`0efc9e666f02…`	`f202fb6c5f17…`

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 Laxative
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIUM POLYCARBOPHIL	625 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8F049NKY49	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308934	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0609468d-ee66-49af-be40-e51965b88f6f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-465-27	Fiber Laxative	90 in 1 BOTTLE	TABLET	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-465	FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET [TOPCO ASSOCIATES, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20250121_0609468d-ee66-49af-be40-e51965b88f6f.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 38 of 42 · 833 matching rows.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8F049NKY49	CALCIUM POLYCARBOPHIL	126040-58-2	CALCIUM POLYCARBOPHIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308934	calcium polycarbophil 625 MG Oral Tablet	PSN	0609468d-ee66-49af-be40-e51965b88f6f	3
308934	calcium polycarbophil 625 MG Oral Tablet	SCD	0609468d-ee66-49af-be40-e51965b88f6f	3
308934	calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet	SY	0609468d-ee66-49af-be40-e51965b88f6f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-465-27	36800046527	90 TABLET in 1 BOTTLE (36800-465-27)	90 tablet	2020-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topcare Fiber Laxative	Topco Associates, LLC \| Guardian Drug Company	2025-01-20	Human OTC Drug Label	3