Rugby Hemorrhoidal

Product NDC
0536-1389
11-digit product format
005361389
Labeler code
0536
Product ID
0536-1389_936469c1-27b6-c9c9-e053-2a95a90ab95c
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride and Fat, Hard
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Rugby Laboratories
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2001-04-23
Marketing end
2020-04-30
Substance
PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD
Active strength
0 g/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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-1389DDiscontinued by firm2026-10-05
excluded packagepackage0536-13890536-1389-12DDiscontinued by firm2026-10-05
excluded packagepackage0536-13890536-1389-35DDiscontinued by firm2026-10-05

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 packagepackage0536-1389-35d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-1389-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1389-35f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1389-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1389-352ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1389-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1389-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1389-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1389-35cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1389-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1389-35cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1389-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1389-35302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1389-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1389-35ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1389-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1389-350efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1389-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1389-35ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1389-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1389-35367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1389-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1389-35557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1389-12557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1389-12EA - Each0536-13894f3f3580-6f23-446d-87b4-5d2f6c03b5f712012-07-24
0536-1389-35EA - Each0536-1389aa581d8b-31ca-4b4b-8d02-9b60ea31c8f612015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAT, HARDACTIVE INGREDIENT8334LX7S21RUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
FAT, HARDACTIVE MOIETY8334LX7S21RUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [RUGBY LABORATORIES]4
Fat, HardACTIVE INGREDIENT8334LX7S21RUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
Fat, HardACTIVE MOIETY8334LX7S21RUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
PhenylephrineACTIVE MOIETY1WS297W6MVRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJRUGBY HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [PREFERRED PHARMACEUTICALS, INC.]1