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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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	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