Home NDC 68382-418 OXYMETAZOLINE HYDROCHLORIDE
Product NDC 68382-418
11-digit product format 683820418
Labeler code 68382
Product ID 68382-418_f98fc905-f9bc-4237-b193-e5be2977df46
Type HUMAN OTC DRUG
Nonproprietary name OXYMETAZOLINE HYDROCHLORIDE
Dosage form SPRAY, METERED
Route NASAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application part341
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2009-09-24
Marketing end 0000-00-00
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 1 mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 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 68382-418-07 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68382-418-07 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68382-418-07 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68382-418-07 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68382-418-07 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68382-418-07 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68382-418-07 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68382-418-07 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68382-418-07 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68382-418-07 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68382-418-07 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68382-418-07 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68382-418-07 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68382-418-07 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-418-07 OXYMETAZOLINE HYDROCHLORIDE 22 mL in 1 INHALER SPRAY, METERED 22 2 68382-418-07 OXYMETAZOLINE HYDROCHLORIDE 1 in 1 CARTON SPRAY, METERED 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYMETAZOLINE HYDROCHLORIDE ACTIVE INGREDIENT K89MJ0S5VY OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 OXYMETAZOLINE ACTIVE MOIETY 8VLN5B44ZY OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 EUCALYPTOL INACTIVE INGREDIENT RV6J6604TK OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 GLYCINE INACTIVE INGREDIENT TE7660XO1C OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-418 OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 Legacy NDC, 2 package rows 20110531_d3ecb8ca-1e02-4dbe-8858-e801b76809e4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68382-418-07 68382041807 22 mL in 1 INHALER 22 ml Historical