Home NDC 0023-5300-30 RHOFADE
Product NDC 0023-5300
Requested package NDC 0023-5300-30
11-digit product format 000235300
Labeler code 0023
Product ID 0023-5300_1acd8f72-9d36-4756-a3b0-3e354f12d7b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymetazoline Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Allergan, Inc.
Application NDA208552
Marketing category NDA
Marketing start 2017-01-18
Marketing end 0000-00-00
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 2023-12-31
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…
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0023-5300-30 2023-07-31 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-35 2023-07-31 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-60 2023-07-31 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-65 2023-07-31 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-30 2023-07-28 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-35 2023-07-28 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-60 2023-07-28 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964 0023-5300-65 2023-07-28 These highlights do not include all the information needed to use RHOFADE ™ topical c ream safely and effectively. See full prescribing information for RHOFADE ™ topical c ream . RHOFADE ™ ( oxymetazoline hydrochloride ) cream , for topical use Initial U.S. Approval: 1964
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0023-5300-30 00023530030 1 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE 1 tube 2017-01-18 0000-00-00 No No Current