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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener plus Stimulant Laxative	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	CARDINAL HEALTH, 110 DBA LEADER	3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce	2026-03-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Walmart Inc.	484d0421-59ea-3783-e063-6394a90af633	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Walmart Inc.	484c2586-9e6f-1ce5-e063-6394a90a0d81	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Walmart Inc.	450ddcbd-7ccd-3670-e063-6294a90ac2bd	2026-03-04	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Amazon.com Services LLC	787ec4b0-c6c5-44ab-a53d-d6d25304f95e	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	3d0d63d7-640d-4e54-a6fd-6b265c79be09	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	9b3b6cea-ab83-4b7c-a425-fd0ac7df426c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	51ed515b-cc51-4ea1-b612-090476135005	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Old East Main Co.	a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	629c5817-13b7-4527-8998-93131ee3529e	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	4df97cdc-e7a2-4350-8f95-a679cdcaff64	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	46b26b44-e065-4337-a071-fa036f897140	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Chain Drug Marketing Association	ef163b24-ce92-4cbc-b45a-4fae3b511949	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Marketing Association	4ee26633-8eb1-4c68-a768-20460404533a	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Chain Drug Marketing Association	3bfdad9c-ac58-4e92-b952-555e8a8351cd	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	2bcab227-42b6-4bff-8363-f6800665755b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	a87dceb2-da73-4d3a-b87c-db2af10471bf	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Kroger Co.	3ae7e275-7bbc-4e62-b30f-013c40a89949	2026-02-27	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	CVS Pharmacy, Inc	0b7736df-c7de-7d00-e063-6294a90aa57e	2026-02-26	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	PD-Rx Pharmaceuticals, Inc.	5d300ea7-78eb-4e19-8333-1e42c73c4c54	2026-02-26	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