FDA.reportPublic FDA data

Vicks Sinex SEVERE CONGESTION

Product NDC
64336-004
11-digit product format
643360004
Labeler code
64336
Product ID
64336-004_4c9adf11-86d9-102b-e063-6394a90af4b4
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Procter & Gamble Manufacturing GmbH
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-27
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.0005 g/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks Sinex SEVERE CONGESTION
Brand name suffix
MOISTURIZING ULTRA FINE MIST
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.0005 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64336-004-01Vicks Sinex SEVERE CONGESTIONMOISTURIZING ULTRA FINE MIST1 in 1 CARTONSPRAY12
64336-004-01Vicks Sinex SEVERE CONGESTIONMOISTURIZING ULTRA FINE MIST15 mL in 1 BOTTLE, SPRAYSPRAY152
64336-004-02Vicks Sinex SEVERE CONGESTIONMOISTURIZING ULTRA FINE MIST2 in 1 CARTONSPRAY22
64336-004-02Vicks Sinex SEVERE CONGESTIONMOISTURIZING ULTRA FINE MIST15 mL in 1 BOTTLE, SPRAYSPRAY152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN464534ee-15f8-3af8-e063-6394a90a3f182
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD464534ee-15f8-3af8-e063-6394a90a3f182
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY464534ee-15f8-3af8-e063-6394a90a3f182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64336-004-01643360004011 BOTTLE, SPRAY in 1 CARTON (64336-004-01) / 15 mL in 1 BOTTLE, SPRAY2026-02-27NoNoCurrent
64336-004-02643360004022 BOTTLE, SPRAY in 1 CARTON (64336-004-02) / 15 mL in 1 BOTTLE, SPRAY2026-06-010Current