Rhofade

Product NDC: 68308-766
11-digit product format: 683080766
Labeler code: 68308
Product ID: 68308-766_a49cde4c-e484-4cb9-85c2-35ba41690f35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: NDA208552
Marketing category: NDA
Marketing start: 2026-07-15
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	N208552-001	RHOFADE	1%	CREAM / TOPICAL	AB	RLD, RS	2017-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208552-001	RHOFADE	1%	CREAM / TOPICAL	AB	RLD, RS	2017-01-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N208552-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208552-001	AB	1	`caaa826d4ba7…`
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 · 313 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208552-001	NP	2020-01-18	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208552-001	NP	2020-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208552-001	NP	2020-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208552-001	NP	2020-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208552-001	NP	2020-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208552-001	NP	2020-01-18	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Rhofade
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
34298db6-647d-480d-88a8-dc53258a5164	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	Mayne Pharma	34298db6-647d-480d-88a8-dc53258a5164	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552 ndc (product): 68308-766
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	Mayne Pharma	f7dbf12e-a802-4261-bae2-c20977698933	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	EPI Health, LLC	e82b5788-a855-4165-a81f-7f15cb874612	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68308-766-30	68308076630	1 TUBE in 1 CARTON (68308-766-30) / 30 g in 1 TUBE	1 tube	2026-07-15	No	No	Current