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 35 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	2c9a1fe7-b77b-436b-8701-9f95f642d001	2024-07-05	Warnings	Exact identifier application number: M007
SENNA	SENNA	Precision Dose, Inc.	e637777e-a39d-4e2f-a95c-4f524aa122f7	2024-07-05	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	GERI-CARE PHARMACEUTICALS, CORP	1c462af8-af1a-391c-e063-6394a90a8b49	2024-07-02	Warnings	Exact identifier application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free	CALCIUM POLYCARBOPHIL	Amerisourcebergen Drug Corporation	4911fb44-e070-46c1-8f90-b78ceb10e51e	2024-06-28	Warnings	Exact identifier application number: M007
Fleet	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	56a7b6c5-d674-4eed-91c2-77f7d18fff32	2024-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	WALMART INC. (see also Equate)	2cf6c9bf-c318-445d-9306-5675b1d424b0	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	WALMART INC. (see also Equate)	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	2791223a-7ac0-47e5-9a6a-4d9a02cfeb63	2024-06-25	Warnings	Exact identifier application number: M007
Fleet	BISACODYL	C.B. Fleet Company, Inc.	4e0d973f-e6dc-48d9-8df3-1d47c87840f1	2024-06-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	TOP CARE (Topco Associates LLC)	3b184800-649b-45d0-9586-8055d6d7fe08	2024-06-20	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA LAXATIVE	Good Sense	9393032e-4343-4ac5-8e91-36013e5ca089	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener	STOOL SOFTENER	Good Sense	64266195-1b07-42c2-98a7-d76c12f74776	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	6c8c7c46-3ded-4e89-8e16-30eeb72aa08b	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	50ca1ce2-885f-4b71-a5fb-90c2cf508ce6	2024-06-14	Warnings	Exact identifier application number: M007
basic care stool softener	DOCUSATE SODIUM	Amazon.com Services LLC	356a889f-ec23-4eb2-a25c-bbe609475155	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	88cc2575-27a1-4514-bc41-bd1eac283814	2024-06-13	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	2b5e1f03-0182-4d1c-8ba0-b1008b1335ad	2024-06-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	1b7edd67-7b14-4fdd-9821-637f4b3c3a2c	2024-06-06	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Patrin Pharma, Inc.	a9f1ef8d-8700-481f-a709-972bb9d27153	2024-05-30	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	5f9cd233-6c46-5b52-e053-2991aa0ab729	2024-05-23	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