Natural Orange Flavor

Product NDC: 68163-571
11-digit product format: 681630571
Labeler code: 68163
Product ID: 68163-571_60366b53-67b0-4db0-9156-402ebcd88ef2
Type: HUMAN OTC DRUG
Nonproprietary name: Psyllium husk
Dosage form: POWDER
Route: ORAL
Labeler: Raritan Pharmaceuticals Inc
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-20
Substance: PSYLLIUM HUSK
Active strength: 3.4 g/12g
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68163-571-72	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68163-571-72	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68163-571-72	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68163-571-72	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68163-571-72	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68163-571-72	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68163-571-72	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Natural Orange Flavor
Brand name suffix: Organic Natural Fiber
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSYLLIUM HUSK	3.4 g/12g

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-04-08	c30129ac-4517-48b5-aafd-e65ec54b340e
2025-04-08	c30129ac-4517-48b5-aafd-e65ec54b340e
2025-01-30	c30129ac-4517-48b5-aafd-e65ec54b340e
2025-01-30	c30129ac-4517-48b5-aafd-e65ec54b340e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68163-571-72	Natural Orange FlavorOrganic Natural Fiber	864 g in 1 CANISTER	POWDER	864		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68163-571	NATURAL ORANGE FLAVOR ORGANIC NATURAL FIBER (PSYLLIUM HUSK) POWDER [RARITAN PHARMACEUTICALS INC]	6	Current NDC, Legacy NDC, 1 package rows	20250410_c30129ac-4517-48b5-aafd-e65ec54b340e.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 11 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	United Natural Foods, Inc. dba UNFI	cb7bc571-295f-47c2-ae93-18cba194752c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Strategic Sourcing Services LLC	e4965086-dcc0-4b34-bb30-81facf7139f3	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Valu Merchandisers Company	cd3e5836-b2f0-41f3-8623-3105c4642491	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Valu Merchandisers Company	a693f6b0-0679-4609-9ca0-dddfa4158c02	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Valu Merchandisers Company	fb358bc3-e479-42e7-8aea-a6a3676f2430	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Valu Merchandisers Company	ff539c1c-9ed3-49be-9b30-1858f12e1e90	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	United Natural Foods, Inc. dba UNFI	bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Walgreens SmoothLAX Soft Chews	MAGNESIUM HYDROXIDE	Walgreens	424e27ce-0b11-9cd2-e063-6294a90a3c21	2026-02-16	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	da013c15-3531-4dc5-b122-bfc99bc494ae	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	db1bc651-1a35-4f92-a917-c6a19f421594	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	The Kroger Co.	e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b	2026-02-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	b2ec06b3-647d-49ab-a392-6db63d96d1e3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Topco Associates LLC	5643f2e0-93e2-4c2e-90a0-fd152150d18a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Topco Associates LLC	d3cc7cb6-098e-413c-b1ad-7ebf5fa35269	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Topco Associates LLC	bc89c4bc-5207-479d-9a3b-e570b412a7ba	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	72f69aa0-381a-4e5c-975d-3a73fdc1b377	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Topco Associates LLC	e9b1fd61-c229-4529-82c2-d6ac5b076082	2026-02-13	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Pinnacle RX LLC	4abbb0e4-e005-bc4e-e063-6394a90a126a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
365 Whole Foods Market Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market, Inc.	4147cdd0-57f6-3857-e063-6394a90afecb	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Your Military Exchanges	27cff497-123c-424a-9c43-57740c00168b	2026-02-12	Warnings, Adverse reactions	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	c30129ac-4517-48b5-aafd-e65ec54b340e	6
824586	psyllium 3400 MG Powder for Oral Suspension	SCD	c30129ac-4517-48b5-aafd-e65ec54b340e	6
824586	psyllium 3.4 GM Powder for Oral Suspension	SY	c30129ac-4517-48b5-aafd-e65ec54b340e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68163-571-72	68163057172	864 g in 1 CANISTER (68163-571-72)	864 g	2019-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Natural Orange Flavor Organic Natural Fiber - Raritan Pharmaceuticals Inc	Raritan Pharmaceuticals Inc	2026-09-23	HUMAN OTC DRUG LABEL	7