Nikzon Hemorrhoidal

Product NDC
50066-423
11-digit product format
500660423
Labeler code
50066
Product ID
50066-423_7d7dd149-d648-3115-e053-2991aa0a02e4
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Genoma Lab USA Inc
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-08
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
3 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct50066-423DDiscontinued by firm2026-10-05
excluded packagepackage50066-42350066-423-25DDiscontinued 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 · 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 packagepackage50066-423-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50066-423-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50066-423-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50066-423-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50066-423-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50066-423-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50066-423-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50066-423-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50066-423-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50066-423-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50066-423-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50066-423-25557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PRAMOXINEACTIVE MOIETY068X84E056NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-423-25500660423251 TUBE in 1 CARTON (50066-423-25) > 25 g in 1 TUBE1 tube2016-11-010000-00-00NoNoCurrent