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 38 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	Care One (Retail Business Services, LLC.)	eb7f3d65-8741-407d-b3f3-1d9dda19684d	2024-03-05	Warnings	Exact identifier application number: M007
Fleet	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f50ba829-16c3-40a7-9822-8d6d00353b33	2024-02-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	4ce62421-97e0-4920-9a6d-9fa1f0f93fe4	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	851a5dda-e72b-4067-a98f-54d3222f646e	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	2ca80e23-f38a-4f77-b536-131cc9f0cf5b	2024-02-23	Warnings	Exact identifier application number: M007
Colon Detox	DOCUSATE SODIUM AND SENNOSIDES	OPMX LLC	0a4d3265-080c-d2ed-e063-6394a90adbee	2024-02-21	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	Best Choice (Valu Merchandisers Company)	4501d718-15a7-4e27-bdb1-8aa2d3ff06d0	2024-02-20	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Best Choice (Valu Merchandisers Company)	72bd251b-4e82-41ef-8362-39f95faf9916	2024-02-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CARDINAL HEALTH, INC. 063997360	10bdd5e6-3db2-8f9e-e063-6394a90a9b3f	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CARDINAL HEALTH, INC. 063997360	10beb3ec-a189-221d-e063-6394a90aabb5	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CARDINAL HEALTH, INC. 063997360	10bebb63-19b3-2e14-e063-6394a90a8d4e	2024-02-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Proficient Rx LP	f9ac0344-5864-4ac1-81bc-16878a5946c5	2024-02-01	Warnings	Exact identifier application number: M007
Purifi Hand Sanitizer	BENZALKONIUM CHLORIDE	Purifi LLC	9267069d-4cf5-4e48-a446-7dbebea16bf5	2024-01-31	Warnings	Exact identifier application number: M007
WOMENS LAXATIVE ENTERIC COATED	BISACODYL	CARDINAL HEALTH	ab34bc89-6738-d284-e053-2a95a90a5dc9	2024-01-11	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE	SENNOSIDES	CARDINAL HEALTH	b7b13bfa-8a94-6f62-e053-2995a90abbf4	2024-01-10	Warnings	Exact identifier application number: M007
FIBER LAXATIVE	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	e4a921c5-1cf7-12ca-e053-2a95a90a6e04	2024-01-03	Warnings	Exact identifier application number: M007
Freskaro Castor Oil	CASTOR OIL	Pharma Nobis, LLC	fbd6bdd5-a7a1-3f28-e053-6294a90aab87	2023-12-28	Warnings	Exact identifier application number: M007
Humco Castor Oil	CASTOR OIL	Pharma Nobis, LLC	e42f9d37-1b07-177a-e053-2a95a90a9b06	2023-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Pharma Nobis, LLC	f0477328-eca1-9043-e053-2995a90aaa3d	2023-12-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Pharma Nobis, LLC	f0489f6f-9e60-7d69-e053-2a95a90a9dfb	2023-12-22	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