ASSURED NASAL RELIEF ORIGINAL

Product NDC
33992-8684
Requested package NDC
33992-8684-5
11-digit product format
339928684
Labeler code
33992
Product ID
33992-8684_db88efcb-e172-5f71-e053-2a95a90a0be1
Type
HUMAN OTC DRUG
Nonproprietary name
OXYMETAZOLINE HYDROCHLORIDE
Dosage form
SPRAY
Route
NASAL
Labeler
GREENBRIER INTERNATIONAL, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-03-08
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage33992-868433992-8684-5IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-8684-5ASSURED NASAL RELIEF ORIGINAL30 mL in 1 BOTTLESPRAY308
33992-8684-5ASSURED NASAL RELIEF ORIGINAL1 in 1 CARTONSPRAY18

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-8684ASSURED NASAL RELIEF ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [GREENBRIER INTERNATIONAL, INC.]8Legacy NDC, 2 package rows20220401_5c86c949-fa0b-413d-9934-d4edb58ece8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN5c86c949-fa0b-413d-9934-d4edb58ece8b8
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD5c86c949-fa0b-413d-9934-d4edb58ece8b8
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY5c86c949-fa0b-413d-9934-d4edb58ece8b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33992-8684-5339928684051 BOTTLE in 1 CARTON (33992-8684-5) > 30 mL in 1 BOTTLE1 bottle2016-11-070000-00-00NoNoCurrent