Reguloid

Product NDC: 0536-4444
Requested package NDC: 0536-4444-89
11-digit product format: 005364444
Labeler code: 0536
Product ID: 0536-4444_84628a32-7331-b71d-e053-2991aa0ae673
Type: HUMAN OTC DRUG
Nonproprietary name: Psyllium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Rugby Laboratories
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-06-22
Marketing end: 2022-01-31
Substance: PSYLLIUM HUSK
Active strength: 3 g/7g
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0536-4444	0536-4444-89	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-4444-54	GM - Gram	0536-4444	6a280f47-196a-48b2-aa36-f2ce986ccbe8	1	2012-07-24
0536-4444-89	GM - Gram	0536-4444	d778605f-9cc3-4364-9bff-0cff1f0df585	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSYLLIUM HUSK	ACTIVE INGREDIENT	0SHO53407G	REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]	2
PSYLLIUM HUSK	ACTIVE MOIETY	0SHO53407G	REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]	2

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	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
1089355	Reguloid 3.4 GM Powder for Oral Suspension	PSN	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
1089355	psyllium 3400 MG Powder for Oral Suspension [Reguloid]	SBD	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
824586	psyllium 3400 MG Powder for Oral Suspension	SCD	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
824586	psyllium 3.4 GM Powder for Oral Suspension	SY	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
1089355	Reguloid 3.4 GM Powder for Oral Suspension	SY	49410209-01ed-4a45-9b6e-59943e3eb9b9	1
1089355	Reguloid 3400 MG Powder for Oral Suspension	SY	49410209-01ed-4a45-9b6e-59943e3eb9b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-4444-89	00536444489	540 g in 1 BOTTLE (0536-4444-89)	540 g	2009-06-22	2022-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
2688 - Rugby	Rugby Laboratories	2019-03-18	HUMAN OTC DRUG LABEL	5
2688 - Rugby	Preferred Pharmaceuticals Inc.	2018-03-30	HUMAN OTC DRUG LABEL	1
Reguloid Psyllium Husk Regular Flavor	A-S Medication Solutions	2017-10-05	HUMAN OTC DRUG LABEL	6