Home NDC 51672-1405-2 Oxymetazoline Hydrochloride
Product NDC 51672-1405
Requested package NDC 51672-1405-2
11-digit product format 516721405
Labeler code 51672
Product ID 51672-1405_5151bebc-ad61-adae-e063-6394a90a2720
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxymetazoline Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA213584
Marketing category ANDA
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 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 · 2 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 51672-1405 51672-1405-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-1405 51672-1405-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A213584-001 OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213584-001 AB
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 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04 a50c72e98297…
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 A213584-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213584-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213584-001 AB 1 a50c72e98297…
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 Oxymetazoline Hydrochloride
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1869816 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1405 OXYMETAZOLINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC 20211012_8a7f2400-5e18-4215-8d2c-f55881706107.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1405-2 51672140502 1 TUBE in 1 CARTON (51672-1405-2) / 30 g in 1 TUBE 1 tube 2026-07-15 0000-00-00 No No Current