OXYMETAZOLINE HYDROCHLORIDE

Product NDC
65841-711
11-digit product format
658410711
Labeler code
65841
Product ID
65841-711_36f5edc8-063f-4506-b856-0c41dd2f7913
Type
HUMAN OTC DRUG
Nonproprietary name
OXYMETAZOLINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Cadila Healthcare Limited
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65841-711IInactivated by FDA2026-10-12
excluded packagepackage65841-71165841-711-07IInactivated by FDA2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65841-711-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65841-711-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65841-711-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65841-711-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65841-711-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65841-711-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65841-711-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65841-711-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65841-711-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65841-711-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65841-711-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65841-711-07557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65841-711-078af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65841-711-07834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65841-711-071332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage65841-711-07fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage65841-711-0786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage65841-711-07bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage65841-711-078dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage65841-711-07e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage65841-711-079bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage65841-711-07110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65841-711-072019-10-29C16284748780-1960f7f55-c7c1-8e05-e053-dbdaa90a074aOxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, 3/4 FL OZ (22 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-711-07OXYMETAZOLINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12
65841-711-07OXYMETAZOLINE HYDROCHLORIDE22 mL in 1 INHALERSPRAY, METERED222

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
GLYCINEINACTIVE INGREDIENTTE7660XO1COXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-711OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]2Legacy NDC, 2 package rows20110531_a63508ff-5161-4f69-bd39-9e0dd5b736de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa63508ff-5161-4f69-bd39-9e0dd5b736de2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa63508ff-5161-4f69-bd39-9e0dd5b736de2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa63508ff-5161-4f69-bd39-9e0dd5b736de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65841-711-07658410711071 in 1 CARTONHistorical