Vicks Sinex Severe

Product NDC: 64336-170
11-digit product format: 643360170
Labeler code: 64336
Product ID: 64336-170_500f54a4-3615-924d-e063-6294a90af20f
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: 2018-12-20
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: Original

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
cfd048c9-2f33-101d-e053-2995a90ad854	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
64336-170-01	Vicks Sinex SevereOriginal	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		8
64336-170-01	Vicks Sinex SevereOriginal	1 in 1 CARTON	SPRAY	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64336-170	VICKS SINEX SEVERE ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PROCTER & GAMBLE MANUFACTURING GMBH]	5	Current NDC, Legacy NDC, 2 package rows	20241012_cfd048c9-2f33-101d-e053-2995a90ad854.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 144 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraCare Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	d6e789c7-a55a-dc9a-e053-2a95a90a2bdb	2024-10-29	Warnings	Exact identifier application number: M012
Careone daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	American Sales Company	31187c98-6706-4962-91f6-022a390cda39	2024-10-28	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	0100f86e-257f-4197-9849-3c4429cdf0f2	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	PHARMACY VALUE ALLIANCE LLC	46bf124a-a44f-4066-b936-852d46da8f40	2024-10-28	Warnings	Exact identifier application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	25a26577-a9f8-49cb-9d75-d8c471e4aaf6	2024-10-28	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e	2024-10-28	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	d38537c6-9553-4e93-a83e-11ed48c955ab	2024-10-28	Warnings	Exact identifier application number: M012
Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	2b3a1997-f382-4843-a44b-d80d1ad21a90	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value Tussin Cough Long Acting	DEXTROMETHORPHAN HBR	Chain Drug Consortium, LLC	0e393287-5bb8-458b-98c4-55fa16674d06	2024-10-28	Warnings	Exact identifier application number: M012
daytime cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1740ccfc-6e68-46f4-a1ba-48fe092f0aa0	2024-10-28	Warnings	Exact identifier application number: M012
night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	d3bd0632-328c-4ad7-bb44-8383e1e51b8c	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value	DEXTROMETHORPHAN HBR, GUAIFENESIN	PHARMACY VALUE ALLIANCE LLC	1ae3c6ac-1646-4c67-a9d5-9c383924b81a	2024-10-28	Warnings	Exact identifier application number: M012
nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	1c341cf5-ac33-4a6e-b023-a23d280d496c	2024-10-25	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	b6d9f421-b236-4660-be7f-85a878f2fc61	2024-10-25	Warnings	Exact identifier application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	f9c3c12b-4efa-4ec4-a156-c403aff81753	2024-10-24	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	1deb60f3-e9be-4756-b0c1-527ef00dc741	2024-10-24	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	51dd467b-aae8-41fa-e054-00144ff8d46c	2024-10-24	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	68a5930b-37db-439d-8fb9-7d7de07d8465	2024-10-24	Warnings	Exact identifier application number: M012
sinus pressure pain and cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	bb0225d5-6c32-2c64-e053-2995a90a829b	2024-10-24	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148	2024-10-24	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	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	Vicks Sinex 12Hr Decongestant 0.05 % Nasal Spray	PSN	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinex Long-Acting]	SBD	cfd048c9-2f33-101d-e053-2995a90ad854	8
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	cfd048c9-2f33-101d-e053-2995a90ad854	8
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	Sinex Long-Acting 0.5 MG/ML Nasal Spray	SY	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	Vicks Sinex 12-HR Decongestant 0.05 % Nasal Spray	SY	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	Vicks Sinex 12-HR Ultra Fine Moisturizing 0.05 % Nasal Spray	SY	cfd048c9-2f33-101d-e053-2995a90ad854	8
1001066	Vicks Sinex Long-Acting 0.05 % Nasal Spray	SY	cfd048c9-2f33-101d-e053-2995a90ad854	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64336-170-01	64336017001	1 BOTTLE, SPRAY in 1 CARTON (64336-170-01) / 15 mL in 1 BOTTLE, SPRAY	2018-12-20	2028-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vicks ® Sinex™ Severe Original Nasal Spray	Procter & Gamble Manufacturing GmbH	2026-04-22	HUMAN OTC DRUG LABEL	8