FDA.reportPublic FDA data

Reguloid

Product NDC
0536-1500
11-digit product format
005361500
Labeler code
0536
Product ID
0536-1500_60c7ea7a-59ef-5feb-e053-2991aa0a698e
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium
Dosage form
CAPSULE
Route
ORAL
Labeler
Rugby Laboratories
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-04-28
Marketing end
2019-11-30
Substance
PSYLLIUM HUSK
Active strength
1 g/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-1500DDiscontinued by firm2026-08-17
excluded packagepackage0536-15000536-1500-60DDiscontinued 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 · 24 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 packagepackage0536-1500-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1500-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1500-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1500-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1500-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1500-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1500-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1500-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1500-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1500-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1500-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1500-60557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1500-60EA - Each0536-1500a5100466-3346-44a1-bfca-68e4422fa02912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSYLLIUM HUSKACTIVE INGREDIENT0SHO53407GREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
PSYLLIUM HUSKACTIVE MOIETY0SHO53407GREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8REGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357REGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
GELATININACTIVE INGREDIENT2G86QN327LREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
ISOBUTYL ALCOHOLINACTIVE INGREDIENT56F9Z98TEMREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4REGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1
SHELLACINACTIVE INGREDIENT46N107B71OREGULOID (PSYLLIUM) CAPSULE [RUGBY LABORATORIES]1