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 36 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	United Natural Foods, Inc. dba UNFI	b1d903a5-1d5f-44d4-9939-a4b86e5a620d	2024-05-23	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8	2024-05-23	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	MEIJER, INC.	11fe5bd0-585a-ad8a-e063-6294a90a3ae8	2024-05-22	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Sam's West, Inc	b14d2495-1092-4063-869f-73a7e8c28708	2024-05-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d	2024-05-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	c0898583-4bbb-41d5-9e84-00cca823024f	2024-05-15	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9c986ca8-d540-49c1-b092-94c1bf837c07	2024-05-09	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	ed20d198-e935-200e-e053-2a95a90a309b	2024-05-02	Warnings	Exact identifier application number: M007
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Major Pharmaceuticals	1768b470-2808-fa46-e063-6394a90ac8d9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Stimulant laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	72f8e8d7-ee38-4bd3-8711-f11fded0cede	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	c1e9863a-c229-4694-b450-6b0e0ad37503	2024-04-30	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	96c7f8bc-be95-40d1-9977-44b7cc6582df	2024-04-22	Warnings	Exact identifier application number: M007
Pedia-Lax	MAGNESIUM HYDROXIDE	C.B. Fleet Company, Inc.	975f24d8-218c-40f4-84a5-558acf34329d	2024-04-11	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	H E B	2f9e2723-53a7-47a8-8c41-87bffc4e50dd	2024-04-09	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	H E B	d047e4e9-b8ac-498e-9fde-8af5d415edaa	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	5b8bcc6c-de03-4d73-a76f-6f4c371cf250	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	H E B	1dd2be7e-bdca-4e43-b853-3ed10b636632	2024-04-08	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	1f11cf85-b094-4ca4-8b48-2d3a9093304b	2024-04-04	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