nasal

Product NDC: 42507-388
11-digit product format: 425070388
Labeler code: 42507
Product ID: 42507-388_ac3c1c7a-c771-41c8-81bc-1d71bfe48250
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: HyVee Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-05-13
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-388-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-388-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-388-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-388-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-388-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-388-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-388-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-388-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-388-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-388-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-388-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-388-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
e8a48a00-3533-4c4d-94e1-8a6c6b35a792	Available on FDA.report

DailyMed Socrata Ingredients#

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

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 105 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	2025-09-05	Warnings	Exact identifier application number: M012
Ephedrine Sulfate	EPHEDRINE SULFATE	Walgreen Company	dc0072f9-7111-1af0-e053-2a95a90aed56	2025-09-04	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc	31aa77e0-cfdb-57a8-e063-6394a90af98c	2025-09-04	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	CVS Pharmacy, Inc.	4bb70a55-de44-3dc1-e054-00144ff8d46c	2025-09-04	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS PHARMACY	a645b31e-7da7-4fe6-a04f-ac794ef52494	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de637b1-3402-db86-e063-6294a90ac981	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	f4a9cfec-0725-8f4a-e053-2995a90a1b4a	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de65c99-6c2d-3650-e063-6394a90aa98c	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Medical Group Care LLC	f4a9d879-4736-4f63-e053-2995a90adeba	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de66240-441c-00ad-e063-6294a90a4a05	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	ff99c57a-e06a-69d3-e053-6394a90a6775	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de7ace0-e389-b751-e063-6394a90ab4e9	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	DISCOUNT DRUG MART	06673358-1afc-4d75-e063-6394a90a6ab1	2025-09-03	Warnings	Exact identifier application number: M012
ValuMeds Cough Relief, Dextromethorphan Hbr	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	b16a81db-d9bc-4cce-8ec2-dc189184931e	2025-09-03	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	256d96f0-67bf-42d2-85ef-f49625c5910f	2025-09-02	Warnings	Exact identifier application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	2256623c-7642-4c39-b022-bfaecc861f1c	2025-09-02	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ef574f18-e28d-46bb-87fd-2f3b4df6dc68	2025-09-02	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger Company	f4429475-47f9-451a-bfcc-24b5ef333923	2025-09-02	Warnings	Exact identifier application number: M012
dg health night time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1	2025-08-29	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Medical Group Care LLC	3d70ba70-eb11-f148-e063-6294a90a4c7c	2025-08-28	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42507-388-10	42507038810	1 BOTTLE, SPRAY in 1 CARTON (42507-388-10) / 30 mL in 1 BOTTLE, SPRAY (42507-388-30)	2002-05-13	No	No	Current