CAREONE

Product NDC: 41520-515
11-digit product format: 415200515
Labeler code: 41520
Product ID: 41520-515_dd1baac1-33a8-427f-a7c6-174424bc66f0
Type: HUMAN OTC DRUG
Nonproprietary name: Psyllium Husk
Dosage form: POWDER
Route: ORAL
Labeler: FOODHOLD USA
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-18
Substance: PSYLLIUM HUSK
Active strength: 3.4 g/5.8g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	41520-515		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	41520-515	41520-515-14	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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: CAREONE
Brand name suffix: Orange Flavored
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSYLLIUM HUSK	3.4 g/5.8g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0SHO53407G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
824586	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
4b1cccd2-e941-4d51-9924-4ca35e3a4429	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-03-25	CAREONE Fiber Supplement Orange Flavor Sugar free
2024-03-25	CAREONE Fiber Supplement Orange Flavor Sugar free
2024-01-30	CAREONE Fiber Supplement Orange Flavor Sugar free
2024-01-30	CAREONE Fiber Supplement Orange Flavor Sugar free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-515-14	CAREONEOrange Flavored	660 g in 1 BOTTLE, PLASTIC	POWDER	660		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-515	CAREONE ORANGE FLAVORED (PSYLLIUM HUSK) POWDER [FOODHOLD USA]	5	Current NDC, Legacy NDC, 1 package rows	20240326_4b1cccd2-e941-4d51-9924-4ca35e3a4429.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 8 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Laxomil	BISACODYL 5MG	Pharmadel LLC	3999935b-d8e8-52a6-e063-6294a90aa2a2	2026-03-20	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Grocery Outlet	c820e6a1-fa23-447a-9ee9-50a1bd617adb	2026-03-19	Warnings	Exact identifier application number: M007
CITRUCEL	METHYLCELLULOSE	Haleon US Holdings LLC	9d5f2244-a610-4d45-b6e8-e79bb17a558f	2026-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	f178b31d-4843-4b91-a0d5-ab5ade835dc2	2026-03-16	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c	2026-03-13	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Old East Main Co.	a1ca668a-3bf9-46a9-8a4f-5cb61547bb81	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Vi-Jon, LLC	b29775df-8470-4fe3-bee3-f0490ea6903f	2026-03-12	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	cc43d514-ee82-4314-99b2-c64380f98779	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Fibercon	CALCIUM POLYCARBOPHIL	Foundation Consumer Brands	7992a4bb-5535-4a1d-867d-a99f7e0c1be7	2026-03-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	cda27a9c-9175-4b07-9c0b-d8d897882965	2026-03-12	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Lemon Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	aa02c9af-22b8-4ec2-9e43-fe073f5e617b	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Grape Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	021ebb61-2466-4272-8f7d-b49cafd08754	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Cherry Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	1f14411b-6833-40e6-b1a5-2b8c5bf709d3	2026-03-11	Warnings	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f83ba007-734d-4910-87cb-02e45285e161	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	57e914fa-8fa2-4221-bb5f-534f0ea0aba7	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f28a9043-e0ee-4b38-95d9-d3f23d400691	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Amerisource Bergen	4caf0bcb-c1bf-0ae7-e063-6294a90a344b	2026-03-10	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	92df761b-da68-4ce9-b02a-a5a74fd6620e	2026-03-10	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	31778652-e60e-4098-8e90-3e4f56b5800c	2026-03-06	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	4c6094b7-c1ef-26a3-e063-6394a90af4cc	2026-03-06	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0SHO53407G	PSYLLIUM HUSK	8063-16-9	PSYLLIUM HUSK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
824586	psyllium 3.4 GM Powder for Oral Suspension	PSN	4b1cccd2-e941-4d51-9924-4ca35e3a4429	6
824586	psyllium 3400 MG Powder for Oral Suspension	SCD	4b1cccd2-e941-4d51-9924-4ca35e3a4429	6
824586	psyllium 3.4 GM Powder for Oral Suspension	SY	4b1cccd2-e941-4d51-9924-4ca35e3a4429	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-515-14	41520051514	660 g in 1 BOTTLE, PLASTIC (41520-515-14)	660 g	2019-04-18	0000-00-00	No	No	Current