FDA.reportPublic FDA data

Major Nasal Decongestant

Product NDC
68788-8744
11-digit product format
687888744
Labeler code
68788
Product ID
68788-8744_48bbc4f3-aa2d-4a52-8ed0-a580eeb30535
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-26
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Major Nasal Decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8744-3Major Nasal Decongestant30 mL in 1 BOTTLE, PUMPSPRAY302
68788-8744-3Major Nasal Decongestant1 in 1 CARTONSPRAY12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8744-3ML - Milliliter68788-87447c7f8d73-ee23-4de9-84b3-4ed1e194a3b812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8744MAJOR NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240927_a302e341-1c00-4c3d-b71f-c4c0b307aa67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa302e341-1c00-4c3d-b71f-c4c0b307aa672
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa302e341-1c00-4c3d-b71f-c4c0b307aa672
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa302e341-1c00-4c3d-b71f-c4c0b307aa672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8744-3687888744031 BOTTLE, PUMP in 1 CARTON (68788-8744-3) / 30 mL in 1 BOTTLE, PUMP2024-09-26NoNoHistorical