FDA.reportPublic FDA data

Nasal

Product NDC
0113-2304
Requested package NDC
0113-2304-10
11-digit product format
001132304
Labeler code
0113
Product ID
0113-2304_962b294a-cbef-44f2-a818-7f029dfae86e
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
L. Perrigo Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1991-07-29
Marketing end
2022-07-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-23040113-2304-10DDiscontinued 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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-2304-10ML - Milliliter0113-2304ebb674c1-fe8c-43ec-859b-32f83801898312022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [L. PERRIGO COMPANY]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-2304-10001132304101 BOTTLE in 1 CARTON (0113-2304-10) > 30 mL in 1 BOTTLE1 bottle1991-07-292022-07-31NoNoCurrent