Reguloid

Product NDC
0536-4445
11-digit product format
005364445
Labeler code
0536
Product ID
0536-4445_8462d0c7-d004-6ed8-e053-2991aa0a68d7
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
2022-02-28
Substance
PSYLLIUM HUSK
Active strength
3 g/12g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-4445DDiscontinued by firm2026-08-17
excluded packagepackage0536-44450536-4445-54DDiscontinued by firm2026-08-17
excluded packagepackage0536-44450536-4445-89DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-4445-54d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-4445-89d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-4445-54f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-4445-89f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-4445-542ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-4445-892ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-4445-54a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-4445-89a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-4445-54cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-4445-89cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-4445-54cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-4445-89cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-4445-54302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-4445-89302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-4445-54ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-4445-89ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-4445-540efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-4445-890efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-4445-54ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-4445-89ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-4445-54367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-4445-89367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-4445-54557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-4445-89557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-4445-54GM - Gram0536-44454ec5bee2-0cf6-45fa-a3e7-602c62c349e712012-07-24
0536-4445-89GM - Gram0536-44457d5d6b96-1820-4351-98bf-4226566942c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSYLLIUM HUSKACTIVE INGREDIENT0SHO53407GREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
PSYLLIUM HUSKACTIVE MOIETY0SHO53407GREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
COW MILKINACTIVE INGREDIENT917J3173FTREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
ORANGE JUICEINACTIVE INGREDIENT5A9KE2L9L3REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
RAW SUGARINACTIVE INGREDIENT8M707QY5GHREGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1
SUCROSEINACTIVE INGREDIENTC151H8M554REGULOID (PSYLLIUM) POWDER, FOR SOLUTION [RUGBY LABORATORIES]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-4445-5400536444554368 g in 1 BOTTLE (0536-4445-54) 368 g2009-06-222022-01-31NoNoCurrent
0536-4445-8900536444589538 g in 1 BOTTLE (0536-4445-89) 538 g2009-06-222022-02-28NoNoCurrent