FIBER TABS

Product NDC: 0904-2500
11-digit product format: 009042500
Labeler code: 0904
Product ID: 0904-2500_44fe77d2-515f-0753-e063-6394a90a62f2
Type: HUMAN OTC DRUG
Nonproprietary name: calcium polycarbophil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
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 TABS
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284308	Internal RxNorm lookup
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
bee100da-b9c9-4261-b6e6-7b3db5715625	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-2500-91	FIBER TABS	90 in 1 BOTTLE	TABLET, FILM COATED	90		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-2500-91	EA - Each	0904-2500	7a5bbbbb-bd50-41f4-a837-42d180545d8b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM POLYCARBOPHIL	ACTIVE INGREDIENT	8F049NKY49	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
POLYCARBOPHIL	ACTIVE MOIETY	W25LM17A4W	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
12-HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-2500	FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 1 package rows	20231212_bee100da-b9c9-4261-b6e6-7b3db5715625.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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Extra Strength	DOCUSATE SODIUM	MEIJER, INC.	e43bd2ed-17c7-4530-af72-81a7ad70069c	2023-10-12	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Care One (Retail Business Services, LLC.)	9adaec97-43e3-48f2-96c8-c508b693676c	2023-10-05	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	TopCo Associates, LLC	83aeb90a-ab00-4e26-aa44-5259dce59018	2021-04-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	9fbe783e-ddd9-445a-852a-00f4ad754880	2021-04-20	Warnings	Exact identifier application number: M007
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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	bee100da-b9c9-4261-b6e6-7b3db5715625	9
284308	Fiber Tab 625 MG Oral Tablet	PSN	bee100da-b9c9-4261-b6e6-7b3db5715625	9
284308	calcium polycarbophil 625 MG Oral Tablet [Fiber Tab]	SBD	bee100da-b9c9-4261-b6e6-7b3db5715625	9
308934	calcium polycarbophil 625 MG Oral Tablet	SCD	bee100da-b9c9-4261-b6e6-7b3db5715625	9
308934	calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet	SY	bee100da-b9c9-4261-b6e6-7b3db5715625	9
284308	Fiber Tab 625 MG Oral Tablet	SY	bee100da-b9c9-4261-b6e6-7b3db5715625	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-2500-91	00904250091	90 TABLET, FILM COATED in 1 BOTTLE (0904-2500-91)	2010-09-01	0000-00-00	No	No	Current