Home NDC 50066-423-25 Nikzon Hemorrhoidal
Product NDC 50066-423
Requested package NDC 50066-423-25
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 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 CETYL ESTERS WAX INACTIVE INGREDIENT D072FFP9GU NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 CETYL PALMITATE INACTIVE INGREDIENT 5ZA2S6B08X NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIKZON HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GENOMA LAB USA INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50066-423-25 50066042325 1 TUBE in 1 CARTON (50066-423-25) > 25 g in 1 TUBE 1 tube 2016-11-01 0000-00-00 No No Current