FDA.reportPublic FDA data

Privine

Product NDC
63736-662
11-digit product format
637360662
Labeler code
63736
Product ID
63736-662_2584355b-c068-4bca-87f6-7854da08610b
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Insight Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-07-16
Marketing end
0000-00-00
Substance
NAPHAZOLINE HYDROCHLORIDE
Active strength
0 mL/20mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-662-022019-10-21C16284748780-1956f9ecf-dfa7-621f-e053-dbdaa90a74adPrivine ® nasal spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-662-02Privine1 in 1 BOXSPRAY11
63736-662-02Privine20 mL in 1 BOTTLESPRAY201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naphazoline HydrochlorideACTIVE INGREDIENTMZ1131787DPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
NaphazolineACTIVE MOIETYH231GF11BVPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74PRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RPRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-662PRIVINE (NAPHAZOLINE HYDROCHLORIDE) SPRAY [INSIGHT PHARMACEUTICALS]1Legacy NDC, 2 package rows20090813_ec2bb7d7-d014-46ed-a836-453e921da4c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046610naphazoline HCl 0.05 % Nasal SprayPSNec2bb7d7-d014-46ed-a836-453e921da4c51
1046611Privine 0.05 % Nasal SprayPSNec2bb7d7-d014-46ed-a836-453e921da4c51
1046611naphazoline hydrochloride 0.5 MG/ML Nasal Spray [Privine]SBDec2bb7d7-d014-46ed-a836-453e921da4c51
1046610naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCDec2bb7d7-d014-46ed-a836-453e921da4c51
1046610naphazoline HCl 0.05 % Nasal SpraySYec2bb7d7-d014-46ed-a836-453e921da4c51
1046611Privine 0.05 % Nasal SpraySYec2bb7d7-d014-46ed-a836-453e921da4c51
1046611Privine 0.5 MG/ML Nasal SpraySYec2bb7d7-d014-46ed-a836-453e921da4c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63736-662-02637360662021 in 1 BOXHistorical