Rhofade

Product NDC: 71180-003
11-digit product format: 711800003
Labeler code: 71180
Product ID: 71180-003_05576e70-fad7-4d3e-8575-ce5ff28750a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxymetazoline Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Aclaris Therapeutics, Inc.
Application: NDA208552
Marketing category: NDA
Marketing start: 2017-01-18
Marketing end: 0000-00-00
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: 1 g/100g
Pharmacologic classes: Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71180-003		I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-15	I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-30	I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-35	I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-45	I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-60	I	Inactivated by FDA	2026-08-07
excluded package	package	71180-003	71180-003-65	I	Inactivated by FDA	2026-08-07

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 3 · 126 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71180-003-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71180-003-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71180-003-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-65	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71180-003-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-65	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71180-003-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-65	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71180-003-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-35	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-65	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71180-003-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-35	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-65	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71180-003-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71180-003-35	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71180-003-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71180-003-65	`0efc9e666f02…`	`f202fb6c5f17…`

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	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#

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
71180-003-15	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71180-003-30	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71180-003-35	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71180-003-45	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71180-003-60	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
71180-003-65	These highlights do not include all the information needed to use RHOFADE ® topical cream safely and effectively. See full prescribing information for RHOFADE ® topical cream. RHOFADE ® (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71180-003-15	Rhofade	3 g in 1 TUBE	CREAM	3	3
71180-003-30	Rhofade	1 in 1 CARTON	CREAM	1	3
71180-003-30	Rhofade	30 g in 1 TUBE	CREAM	30	3
71180-003-35	Rhofade	30 g in 1 BOTTLE, PUMP	CREAM	30	3
71180-003-35	Rhofade	1 in 1 CARTON	CREAM	1	3
71180-003-45	Rhofade	45 g in 1 TUBE	CREAM	45	3
71180-003-45	Rhofade	1 in 1 CARTON	CREAM	1	3
71180-003-60	Rhofade	1 in 1 CARTON	CREAM	1	3
71180-003-60	Rhofade	60 g in 1 TUBE	CREAM	60	3
71180-003-65	Rhofade	60 g in 1 BOTTLE, PUMP	CREAM	60	3
71180-003-65	Rhofade	1 in 1 CARTON	CREAM	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71180-003-30	GM - Gram	71180-003	35e148e9-531a-48f2-a4d3-69a6e63450ef	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71180-003	RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [ACLARIS THERAPEUTICS, INC.]	3	Legacy NDC, 11 package rows	20191206_8968299e-2a4f-41a8-9088-6343ea6c91f4.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.

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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1869816	oxymetazoline HCl 1 % Topical Cream	PSN	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869821	Rhofade 1 % Topical Cream	PSN	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869821	oxymetazoline hydrochloride 10 MG/ML Topical Cream [Rhofade]	SBD	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869816	oxymetazoline hydrochloride 10 MG/ML Topical Cream	SCD	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869816	oxymetazoline HCl 1 % Topical Cream	SY	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869821	Rhofade 1 % Topical Cream	SY	8968299e-2a4f-41a8-9088-6343ea6c91f4	3
1869821	Rhofade 10 MG/ML Topical Cream	SY	8968299e-2a4f-41a8-9088-6343ea6c91f4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71180-003-15	71180000315	3 g in 1 TUBE (71180-003-15)	3 g	2017-01-18	0000-00-00	No	No	Current
71180-003-30	71180000330	1 TUBE in 1 CARTON (71180-003-30) > 30 g in 1 TUBE	1 tube	2017-01-18	0000-00-00	No	No	Current
71180-003-35	71180000335	1 BOTTLE, PUMP in 1 CARTON (71180-003-35) > 30 g in 1 BOTTLE, PUMP		2017-01-18	0000-00-00	No	No	Current
71180-003-45	71180000345	1 TUBE in 1 CARTON (71180-003-45) > 45 g in 1 TUBE	1 tube	2017-01-18	0000-00-00	No	No	Current
71180-003-60	71180000360	1 TUBE in 1 CARTON (71180-003-60) > 60 g in 1 TUBE	1 tube	2017-01-18	0000-00-00	No	No	Current
71180-003-65	71180000365	1 BOTTLE, PUMP in 1 CARTON (71180-003-65) > 60 g in 1 BOTTLE, PUMP		2017-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rhofade	Aclaris Therapeutics, Inc. \| DPT Laboratories, Ltd.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	3