nasal

Product NDC: 37808-004
11-digit product format: 378080004
Labeler code: 37808
Product ID: 37808-004_91fa3ae3-b502-4320-8167-68893aa41e6d
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: H E B
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-02
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
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: nasal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	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
3c301993-642a-487c-96a2-ebc4ef90dc88	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-004-10	nasal	1 in 1 CARTON	SPRAY	1		6
37808-004-10	nasal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-004	NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]	6	Current NDC, Legacy NDC, 2 package rows	20241105_3c301993-642a-487c-96a2-ebc4ef90dc88.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 109 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viva Porru Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Menper Distributors, Inc.	0dfadfe3-9e40-0eee-e063-6294a90a00c3	2025-07-22	Warnings	Exact identifier application number: M012
leader childrens allergy relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. dba Leader	40d697b7-dc59-4d24-8d46-db635e01b9d5	2025-07-22	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Chain Drug Consortium	34005c55-3176-4f28-9a3b-7dc6fefd01fe	2025-07-19	Warnings	Exact identifier application number: M012
Sinus Relief Daytime Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	73a77a13-983b-4e65-bb3c-2ba5e9f33a3e	2025-07-19	Warnings	Exact identifier application number: M012
QUALITY CHOICE No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	7cb6ad04-7847-46b9-b371-0a3473001c79	2025-07-18	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Chain Drug Consortium	270e9221-d305-4148-b523-741e02fe733f	2025-07-18	Warnings	Exact identifier application number: M012
ACTISPEC PSE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	5def1555-87f4-41d5-8a5c-be560aa8f1e2	2025-07-17	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1a17b24a-8022-4e2f-e063-6294a90af276	2025-07-17	Warnings	Exact identifier application number: M012
BULPOL Smoking Patches	MENTHOL	Jiashen International Trade Limited	3a1cc0e1-fabf-52b9-e063-6394a90ae35e	2025-07-17	Warnings	Exact identifier application number: M012
Ampigrin Ultra Forte Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e11e71c3-fe7c-77c7-e053-2995a90a34b2	2025-07-17	Warnings	Exact identifier application number: M012
Nitecin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	dfb56532-6f72-1e4d-e053-2a95a90a1c05	2025-07-17	Warnings	Exact identifier application number: M012
tabcin NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	0b3ed2bb-88ed-699e-e063-6394a90ac023	2025-07-17	Warnings	Exact identifier application number: M012
Pentrexcilina Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e11e5c17-28f2-7186-e053-2995a90a51f6	2025-07-17	Warnings	Exact identifier application number: M012
Viro Flu PM Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e1553da8-3a89-e258-e053-2a95a90a4725	2025-07-17	Warnings	Exact identifier application number: M012
ACTICON PEDIATRIC	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23	2025-07-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Demoulas Super Markets, Inc	397f5acd-31c0-683e-e063-6394a90a7e54	2025-07-16	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	19ad2cca-c1cb-019c-e063-6294a90a5644	2025-07-16	Warnings	Exact identifier application number: M012
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8ea03891-2fbc-4413-8e6d-de903d426f8d	2025-07-16	Warnings	Exact identifier application number: M012
up and up nighttime flu and severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	df488727-b913-440b-9a0b-cce3ae143bf2	2025-07-15	Warnings	Exact identifier application number: M012
Topcare DayTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	bb9663e3-fd11-4e72-bf85-fee4841b795f	2025-07-15	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	3c301993-642a-487c-96a2-ebc4ef90dc88	6
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	3c301993-642a-487c-96a2-ebc4ef90dc88	6
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	3c301993-642a-487c-96a2-ebc4ef90dc88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-004-10	37808000410	1 BOTTLE, SPRAY in 1 CARTON (37808-004-10) / 30 mL in 1 BOTTLE, SPRAY	2014-12-02	0000-00-00	No	No	Current