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 162 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Cold and Cough Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Safeway, Inc.	cbbec807-f882-4c6a-b1cd-c7fd5ce70cad	2024-05-15	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742	2024-05-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	f658a03b-6fc2-4b63-b3ab-7e886fbf20b4	2024-05-15	Warnings	Exact identifier application number: M012
AXIV DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	18704e66-ee8f-315d-e063-6294a90a5282	2024-05-14	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	187622dc-ecde-181d-e063-6294a90a4e8f	2024-05-14	Warnings	Exact identifier application number: M012
Lemon Mint Drops	MENTHOL	Target Corporation Inc.	1876df19-398a-23d8-e063-6394a90ae7e8	2024-05-14	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway, Inc.	6c952c81-c8b6-4e74-abd8-781f6f44736b	2024-05-14	Warnings	Exact identifier application number: M012
Pain and Sinus Reliever	ACETAMINOPHEN AND PHENYLEPHRINE	JHK DBA American Safety & First Aid	249373c6-f56f-4bd3-9cef-98b7ee73457d	2024-05-14	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	fea71cb9-e044-4729-ad26-1db0cdb9dd11	2024-05-14	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	2024-05-14	Warnings	Exact identifier application number: M012
Day Time Cold and Flu Relief non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	cc450f89-a156-48e0-82ae-19782f13c2ca	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	a8df5c04-0f92-4013-b3e5-2b45009a7b8d	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Safeway, Inc.	f762600a-f4b1-4869-a04b-8431c3d8a3e3	2024-05-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	ef0cd436-5e81-47a7-92d6-58495283ab28	2024-05-13	Warnings	Exact identifier application number: M012
Tussin Cough Sugar Free	DEXTROMETHORPHAN HBR GUAIFENESIN	P & L Development, LLC	7ed2fe86-3346-4308-a9b6-6a264f879b02	2024-05-09	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	10106c90-f2f0-508e-e063-6294a90a544b	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	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