Nasal

Product NDC
0904-5711
11-digit product format
009045711
Labeler code
0904
Product ID
0904-5711_936359f4-15f1-823a-e053-2a95a90ae295
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Major Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-03-17
Marketing end
2021-01-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-5711DDiscontinued by firm2026-08-11
excluded packagepackage0904-57110904-5711-30DDiscontinued by firm2026-08-11
excluded packagepackage0904-57110904-5711-35DDiscontinued by firm2026-08-11

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 · 36 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 packagepackage0904-5711-35d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-5711-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5711-35f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5711-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5711-352ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5711-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5711-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5711-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5711-35cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5711-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5711-35cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5711-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5711-35302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5711-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5711-35ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5711-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5711-350efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5711-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5711-35ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5711-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5711-35367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5711-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5711-35557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5711-30557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5711-30ML - Milliliter0904-57115f70d9ad-76e0-4189-9c3f-13968c268b4512012-07-24
0904-5711-35ML - Milliliter0904-57111e9c80cd-6892-4c20-b4b4-f917747bba5312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
OxymetazolineACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS, INC.]2
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
PovidoneINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]1