nasal

Product NDC: 41250-388
11-digit product format: 412500388
Labeler code: 41250
Product ID: 41250-388_d8626005-e7bc-47b2-9c1e-763f35873bf1
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline HCl
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-09-11
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: 2027-12-31

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
3984cbc3-b60c-40a7-bc3a-7d1f600503ac	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
41250-388-10	nasal	30 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	30		5
41250-388-10	nasal	1 in 1 CARTON	SPRAY, METERED	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-388	NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [MEIJER DISTRIBUTION INC]	5	Current NDC, Legacy NDC, 2 package rows	20240906_3984cbc3-b60c-40a7-bc3a-7d1f600503ac.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 153 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	Warnings	Exact identifier application number: M012
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	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	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	5
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	5
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-388-10	41250038810	1 BOTTLE, SPRAY in 1 CARTON (41250-388-10) / 30 mL in 1 BOTTLE, SPRAY	2002-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nasal Spray Drug Facts	Meijer Distribution Inc	2024-08-27	HUMAN OTC DRUG LABEL	5