VICKS SINEX SEVERE CONGESTION

Product NDC: 64336-003
11-digit product format: 643360003
Labeler code: 64336
Product ID: 64336-003_5ce119b7-e871-ce49-e063-6294a90a2348
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

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 CONGESTION
Brand name suffix: ORIGINAL Ultra Fine Mist
Listing expiration: 2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64336-003-01	VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	4
64336-003-01	VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist	1 in 1 CARTON	SPRAY	1	4
64336-003-02	VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist	2 in 1 CARTON	SPRAY	2	4
64336-003-02	VICKS SINEX SEVERE CONGESTIONORIGINAL Ultra Fine Mist	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	4

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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	869e950c-5861-4840-aaad-b0342790d62b	2026-02-10	Warnings	Exact identifier application number: M012
CareOne Night TIme Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25	2026-02-10	Warnings	Exact identifier application number: M012
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Sportpharm LLC	d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	f3fc270a-92fc-46d5-b187-44e875c3abb9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	d5c8b248-6d82-4eac-881c-0b9d0a0de8f1	2026-02-09	Warnings	Exact identifier application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	d07112dd-27df-46cc-b7c3-af8ba7601d06	2026-02-09	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	48f7933e-6582-638c-e063-6394a90abfe5	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Retail Business Services, LLC	4fb46860-2bf9-41a7-89eb-31c259c61107	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Sportpharm LLC	909dacfa-50d3-4bcf-b2df-5405427cfaad	2026-02-06	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f91b7c1f-e074-4767-b9c8-dbf1937a6a0f	2026-02-06	Warnings	Exact identifier application number: M012
Severe Allergy And Sinus Headache Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	b3c744b8-aa93-505d-f8cf-07995da4283d	2026-02-06	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	WinCo Foods, LLC	911e6a51-c0f0-491a-b70c-00011ed5e35b	2026-02-06	Warnings	Exact identifier application number: M012
Severe Sinus Daytime, Non-Drowsy	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cc0dc951-5024-4517-9d38-a01699407e7e	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Pharmacy Value Alliance, LLC	d836c3e2-3b69-41f3-b166-21270550e8ab	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Publix Super Markets, Inc.	81b1d5bb-f813-4f79-9559-2494db33ad3c	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	6499f854-2995-48cb-9c80-be6524b3db43	2026-02-05	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	52a398eb-e593-458b-9c42-6f653ca391be	2026-02-04	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Hy-Vee, Inc.	446de381-6685-748d-e063-6394a90a1b73	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	85aadc86-d979-41a1-849a-e2ccc9014429	2026-02-04	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	fa8c154c-56c6-47de-8e43-9e012b4be95f	2026-02-04	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	4645336e-40d8-89e6-e063-6294a90a7655	4
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	4645336e-40d8-89e6-e063-6294a90a7655	4
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	4645336e-40d8-89e6-e063-6294a90a7655	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64336-003-01	64336000301	1 BOTTLE, SPRAY in 1 CARTON (64336-003-01) / 15 mL in 1 BOTTLE, SPRAY	2026-02-27	No	No	Current
64336-003-02	64336000302	2 BOTTLE, SPRAY in 1 CARTON (64336-003-02) / 15 mL in 1 BOTTLE, SPRAY	2026-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vicks ® Sinex™ SEVERE CONGESTION ULTRA FINE MIST, Original	Procter & Gamble Manufacturing GmbH,	2026-10-02	HUMAN OTC DRUG LABEL	5