Home NDC 69646-704-01 Novacort
Product NDC 69646-704
Requested package NDC 69646-704-01
11-digit product format 696460704
Labeler code 69646
Product ID 69646-704_c5eda61a-4251-315a-e053-2a95a90a66ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone acetate and pramoxine hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Novum Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2015-03-01
Marketing end 2021-08-31
Substance HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength 20 mg/g; mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 HYDROCORTISONE ACETATE ACTIVE INGREDIENT 3X7931PO74 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 DIMETHYL ISOSORBIDE INACTIVE INGREDIENT SA6A6V432S NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 HAMAMELIS VIRGINIANA TOP WATER INACTIVE INGREDIENT NT00Y05A2V NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 STEAROXYTRIMETHYLSILANE INACTIVE INGREDIENT 9862TW94B2 NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NOVACORT (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) GEL [NOVUM PHARMA, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69646-704-01 69646070401 1 g in 1 PACKET (69646-704-01) 1 g 2015-03-01 2021-08-31 No No Current