Quality Choice Nasal

Product NDC
63868-080
11-digit product format
638680080
Labeler code
63868
Product ID
63868-080_4647ee61-9bac-4ade-b1a5-93f97fc6c461
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-04-16
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-080-012024-01-30C16284748780-11030e365-1575-111a-e063-dadaa90a10e2Quality Choice Nasal Spray Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-080-01Quality Choice NasalMaximum Strength30 mL in 1 BOTTLE, SPRAYSPRAY303
63868-080-01Quality Choice NasalMaximum Strength1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-080QUALITY CHOICE NASAL MAXIMUM STRENGTH (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC, 2 package rows20220119_b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNb5aa76eb-acc8-495f-85c9-bfdbb2d80e2a3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDb5aa76eb-acc8-495f-85c9-bfdbb2d80e2a3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYb5aa76eb-acc8-495f-85c9-bfdbb2d80e2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-080-01638680080011 BOTTLE, SPRAY in 1 CARTON (63868-080-01) > 30 mL in 1 BOTTLE, SPRAY2019-04-160000-00-00NoNoCurrent