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 85 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	770c0e4f-0eed-4b8c-85a5-761b6a84db62	2025-12-02	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WAL-MART STORES INC	a2a7e568-bff8-4818-a31d-7c2efa1859c3	2025-12-02	Warnings	Exact identifier application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET	Lil' Drug Store Products, Inc.	44fa0193-2a19-bdc1-e063-6394a90a60e8	2025-12-02	Warnings	Exact identifier application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44fb9958-d771-f4b3-e063-6294a90a9135	2025-12-02	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	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