Home NDC 51862-765 Rhofade
Product NDC 51862-765
11-digit product format 518620765
Labeler code 51862
Product ID 51862-765_1314d411-e0a5-402b-89ff-49847937838d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxymetazoline hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Mayne Pharma
Application NDA208552
Marketing category NDA
Marketing start 2024-10-24
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 10 mg/g
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208552-001 RHOFADE OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB RLD, RS 2017-01-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208552-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208552-001 7812049 2028-05-02 U-1959 2017-02-09 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 N208552-001 12350255 2035-06-11 U-3494 2025-07-17 N208552-001 9974773 2035-06-11 U-2306 2018-05-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208552-001 RHOFADE 1% CREAM / TOPICAL RLD, RS 2017-01-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208552-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 299 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 12350255 2035-06-11 U-3494 2025-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208552-001 9974773 2035-06-11 U-2306 2018-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 12350255 2035-06-11 U-3494 2025-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208552-001 9974773 2035-06-11 U-2306 2018-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 12350255 2035-06-11 U-3494 2025-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208552-001 9974773 2035-06-11 U-2306 2018-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208552-001 9974773 2035-06-11 U-2306 2018-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208552-001 9974773 2035-06-11 U-2306 2018-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 8815929 2024-01-22 U-1959 2018-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 8420688 2024-08-02 U-1959 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 7812049 2028-05-02 U-1959 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 8883838 2031-12-01 Drug product 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 10335391 2035-06-11 U-2567 2019-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 10751325 2035-06-11 U-2921 2020-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208552-001 11517560 2035-06-11 U-3494 2022-12-29 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Rhofade
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1869816 Internal RxNorm lookup 1869821 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-765 RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [MAYNE PHARMA] 1 Current NDC, 4 package rows 20241025_f7dbf12e-a802-4261-bae2-c20977698933.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51862-765-00 51862076500 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE 15 tube 2025-07-11 No No Current 51862-765-30 51862076530 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE 1 tube 2024-10-24 No No Current