Vicks Sinex SEVERE

Product NDC: 64336-173
11-digit product format: 643360173
Labeler code: 64336
Product ID: 64336-173_500f5f4c-688a-a8a5-e063-6394a90aac20
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: 2020-05-01
Marketing end: 2028-02-28
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .0005095 g/mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Vicks Sinex SEVERE
Brand name suffix: VapoCOOL ULTRA FINE MIST

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.0005095 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup
1001066	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d0768332-7c24-7c30-e053-2a95a90a26d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64336-173-01	Vicks Sinex SEVEREVapoCOOL ULTRA FINE MIST	15 mL in 1 BOTTLE, PUMP	SPRAY	15		9
64336-173-01	Vicks Sinex SEVEREVapoCOOL ULTRA FINE MIST	1 in 1 CARTON	SPRAY	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64336-173	VICKS SINEX 12 HOUR DECONGESTANT ULTRA FINE MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PROCTER & GAMBLE MANUFACTURING GMBH]	6	Current NDC, Legacy NDC, 2 package rows	20241012_d0768332-7c24-7c30-e053-2a95a90a26d4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 146 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba8ade-3441-f243-e053-2995a90a1230	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba22ac-c38d-a42e-e053-2995a90a6900	2024-10-21	Warnings	Exact identifier application number: M012
Diphenhydramine HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	25034563-6422-daf6-e063-6394a90af980	2024-10-21	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	198add5f-20b7-75b0-e063-6394a90a6bd4	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	dae33df8-2294-4242-a25b-2d89d1f63b23	2024-10-18	Warnings	Exact identifier application number: M012
sinus pressure and pain pe	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a7931e4c-8a5e-66e2-e053-2995a90af2a4	2024-10-18	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	570ea130-6a99-446e-9f97-14fc95809006	2024-10-18	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a14999e3-a9d9-0a1f-e053-2995a90af7b3	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a793000b-3ef9-5662-e053-2a95a90ad0da	2024-10-18	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime and Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	37455f86-ab21-472b-9e80-40324699f3ca	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3396a27-8643-71fa-e053-2a95a90a713d	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3397f69-3267-ca0b-e053-2995a90a7db5	2024-10-18	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	747512a2-3b6d-496b-ab80-819060314163	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	9daf7f40-d9c5-4367-be41-894208358fc1	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	608e6808-29e4-40bc-8496-24c092681a1b	2024-10-18	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	665db127-ee04-46c4-bff0-e0fe9950c3e2	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8	2024-10-18	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	604d7e53-4bfd-4cdd-aed2-b304ae82ce44	2024-10-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	4d93a703-c905-4fb3-b772-11c207065d4d	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	62c35320-87b5-46e2-9f6f-cb0882bdb52e	2024-10-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray	PSN	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]	SBD	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	Sinex Long-Acting 0.5 MG/ML Nasal Spray	SY	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray	SY	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray	SY	d0768332-7c24-7c30-e053-2a95a90a26d4	9
1001066	Vicks Sinex Long-Acting 0.05 % Nasal Spray	SY	d0768332-7c24-7c30-e053-2a95a90a26d4	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64336-173-01	64336017301	1 BOTTLE, PUMP in 1 CARTON (64336-173-01) / 15 mL in 1 BOTTLE, PUMP	2020-05-01	2028-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vicks ® Severe Sinex™ VapoCOOL CONGESTION RELIEF	Procter & Gamble Manufacturing GmbH	2026-04-22	HUMAN OTC DRUG LABEL	9