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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Panadol Cold and Flu Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3417993d-8e3c-23d6-e063-6394a90a7d50	2026-04-29	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	509f233e-ff01-8927-e063-6394a90a9929	2026-04-29	Warnings	Exact identifier application number: M012
Broncomiel Adults	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509c61d3-ae16-be5c-e063-6294a90a68da	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	TOP CARE (Topco Associates LLC)	aa1eb90c-e565-455f-8978-6f2f9e00a814	2026-04-29	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	e1280355-da81-489f-9bd2-ffea9a68010c	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	7b095ec5-9951-4491-9b68-7ac0a7f10053	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOP CARE (Topco Associates LLC)	98dd0ba6-0109-46b2-92df-11a030984240	2026-04-28	Warnings	Exact identifier application number: M012
Pain, Headache and Congestion	ACETAMINOPHEN, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	41a77cbb-6a4d-46a4-ab27-c7affa2cc682	2026-04-28	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	dd7da15a-4e0b-405f-e053-2995a90a06d2	2026-04-28	Warnings	Exact identifier application number: M012
CAREONE CHILDRENS COLD COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Retail Business Services, LLC	382f7d51-ceb8-4bdf-9bd5-440b50c65cd3	2026-04-28	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	1a520b4f-6a4b-4e37-94c5-9387f2e4c34a	2026-04-27	Warnings	Exact identifier application number: M012
Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kroger	49a7cd2a-8c0e-2196-e063-6294a90a134a	2026-04-27	Warnings	Exact identifier application number: M012
Guaifenesin,Dextromethorphan Hbr	GUAIFENESIN,DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	3e5d978f-cc70-60a5-e063-6394a90a67d3	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	36ced59c-12dc-441f-e063-6294a90a3239	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Softgel Healthcare Private Limited	30ab39f3-27cc-5728-e063-6394a90a9cbe	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	353f71f7-81e0-08c2-e063-6294a90acb49	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	Softgel Healthcare Pvt Ltd	353ef34f-760d-ae92-e063-6294a90a5b4a	2026-04-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	507214ad-1e06-fe21-e063-6294a90a59cd	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50738a43-7299-270c-e063-6294a90af2cc	2026-04-27	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