Breaze

Product NDC
20146-4000
11-digit product format
201464000
Labeler code
20146
Product ID
20146-4000_9dcf7331-9e1e-45e2-96d4-24999bf99e0b
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Samson Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20146-4000-2Breaze Nasal Moisturizing1 in 1 CARTONSPRAY12
20146-4000-2Breaze Nasal Moisturizing30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VYBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ABREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
PovidonesINACTIVE INGREDIENTFZ989GH94EBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RBREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20146-4000BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20230718_9a165a12-43d3-4e14-a7ba-bfce579430d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN9a165a12-43d3-4e14-a7ba-bfce579430d62
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD9a165a12-43d3-4e14-a7ba-bfce579430d62
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY9a165a12-43d3-4e14-a7ba-bfce579430d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
20146-4000-2201464000021 in 1 CARTONHistorical