Major Nasal Decongestant

Product NDC
68071-3858
11-digit product format
680713858
Labeler code
68071
Product ID
68071-3858_36b1eb59-ef20-3e53-e063-6294a90ab5ab
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-31
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
68071-3858-3Major Nasal Decongestant1 in 1 CARTONSPRAY11
68071-3858-3Major Nasal Decongestant30 mL in 1 BOTTLE, PUMPSPRAY301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN36b1a7e0-c8b9-0890-e063-6394a90ab13a1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD36b1a7e0-c8b9-0890-e063-6394a90ab13a1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY36b1a7e0-c8b9-0890-e063-6394a90ab13a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3858-3680713858031 BOTTLE, PUMP in 1 CARTON (68071-3858-3) / 30 mL in 1 BOTTLE, PUMP2023-12-31NoNoCurrent