Home NDC 73687-062-25 UPNEEQ
Product NDC 73687-062
Requested package NDC 73687-062-25
11-digit product format 736870062
Labeler code 73687
Product ID 73687-062_3825ad82-1aa8-44bd-ae39-07d7f8984287
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymetazoline hydrochloride ophthalmic
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler RVL Pharmaceuticals, Inc.
Application NDA212520
Marketing category NDA
Marketing start 2020-08-21
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 1 mg/mL
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
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 73687-062 73687-062-25 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N212520-001 UPNEEQ OXYMETAZOLINE HYDROCHLORIDE 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212520-001 10912765 2031-08-26 U-2849 2021-02-10 N212520-001 8357714 2031-08-26 U-2849 2020-07-14 N212520-001 9867808 2031-08-26 U-2849 2020-07-14 N212520-001 10799481 2039-12-16 U-2849 2020-10-20 N212520-001 10814001 2039-12-16 Drug product 2020-11-02 N212520-001 10898573 2039-12-16 Drug product 2021-01-27 N212520-001 10940138 2039-12-16 U-2849 2021-03-10 N212520-001 11103482 2039-12-16 Drug product 2021-09-10 N212520-001 11311515 2039-12-16 Drug product 2022-05-03 N212520-001 11324722 2039-12-16 U-2849 2022-05-11 N212520-001 11541036 2039-12-16 Drug product 2023-01-05 N212520-001 11701343 2039-12-16 U-2849 2023-11-07 N212520-001 12605363 2039-12-16 Drug product 2026-05-07 N212520-001 12648930 2039-12-16 U-2849 2026-06-23
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.
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 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212520-001 UPNEEQ 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-07-08 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 11 · 415 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 N212520-001 10912765 2031-08-26 U-2849 2021-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 8357714 2031-08-26 U-2849 2020-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 9867808 2031-08-26 U-2849 2020-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 10799481 2039-12-16 U-2849 2020-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 10814001 2039-12-16 Drug product 2020-11-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 10898573 2039-12-16 Drug product 2021-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 10940138 2039-12-16 U-2849 2021-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 11103482 2039-12-16 Drug product 2021-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 11311515 2039-12-16 Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 11324722 2039-12-16 U-2849 2022-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 11541036 2039-12-16 Drug product 2023-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 11701343 2039-12-16 U-2849 2023-11-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 12605363 2039-12-16 Drug product 2026-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212520-001 12648930 2039-12-16 U-2849 2026-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212520-001 10912765 2031-08-26 U-2849 2021-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 8357714 2031-08-26 U-2849 2020-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 9867808 2031-08-26 U-2849 2020-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 10799481 2039-12-16 U-2849 2020-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 10814001 2039-12-16 Drug product 2020-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 10898573 2039-12-16 Drug product 2021-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 10940138 2039-12-16 U-2849 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 11103482 2039-12-16 Drug product 2021-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 11311515 2039-12-16 Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 11324722 2039-12-16 U-2849 2022-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 11541036 2039-12-16 Drug product 2023-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 11701343 2039-12-16 U-2849 2023-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 12605363 2039-12-16 Drug product 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212520-001 12648930 2039-12-16 U-2849 2026-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212520-001 10912765 2031-08-26 U-2849 2021-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 8357714 2031-08-26 U-2849 2020-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 9867808 2031-08-26 U-2849 2020-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 10799481 2039-12-16 U-2849 2020-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 10814001 2039-12-16 Drug product 2020-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 10898573 2039-12-16 Drug product 2021-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 10940138 2039-12-16 U-2849 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 11103482 2039-12-16 Drug product 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 11311515 2039-12-16 Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 11324722 2039-12-16 U-2849 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 11541036 2039-12-16 Drug product 2023-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212520-001 11701343 2039-12-16 U-2849 2023-11-07 011fe1cb6892…
Observed Orange Book exclusivity history# 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 UPNEEQ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 1 mg/mL
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 2391749 Internal RxNorm lookup 2391754 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 73687-062 UPNEEQ (OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [RVL PHARMACEUTICALS, INC.] 28 Current NDC, Legacy NDC, 7 package rows 20241027_cf6c9a1f-2367-46d2-99c3-c7d67ec6f519.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73687-062-25 73687006225 15 AMPULE in 1 CARTON (73687-062-25) > .3 mL in 1 AMPULE (73687-062-80) 15 ampule 2020-08-21 0000-00-00 Yes No Current