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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	Better Living Brands, LLC	7f2f1b30-497a-4c53-accc-8455169b17b3	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	cc97cfb5-cd40-4589-942a-5bee611a2812	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	0ac1896d-7ed9-44e5-bf07-147826237273	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Chain Drug Marketing Association	4a003bb1-425d-cd97-e063-6294a90a5dda	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	d8176ef6-cc68-4185-b5eb-e887562f6aaa	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	07732845-c9ce-47bb-8b63-36a3d5ddf8b7	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
stimulant laxative	BISACODYL	BIONPHARMA INC.	4b1f7db3-c6a8-7f6a-e063-6394a90a5829	2026-02-22	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	ff6c8022-9522-4eae-b8ff-994ee37fba06	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Perrigo Direct, Inc	09e32476-1c60-4f1e-a51c-5fab2e744b30	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	22991685-8228-41e1-a13e-f57961e8dd0e	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	24478279-9a11-4e12-956d-57dc7debf941	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Perrigo Direct, Inc	f1656280-fad9-4922-9d5c-be774a8b1422	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	3b8eae67-9e27-46bd-ab2b-02c719786bab	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Meijer, Inc.	c4d03837-193b-4817-8b78-fbdfb9122f19	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	2070a4a6-7968-49f2-84ec-53bd1cd82445	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Meijer, Inc.	652d1da9-a71f-4113-9ef3-da0916724625	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
SENNA-S	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx LLC	d148be81-79b4-41f7-b8d8-a0e85b661592	2026-02-18	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Target Corporation	a8e52a22-7c30-40c0-8f78-523775743bfb	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Target Corporation	526508f0-e908-4e3d-88f5-404a95f6de76	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
CVS Pharmacy	SALINE LAXATIVE	CVS Pharmacy	edd58c52-18de-4ec4-aec3-44f3e17607a7	2026-02-17	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