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 95 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Original	OXYMETAZOLINE HYDROCHLORIDE	SAFEWAY, INC.	f7ad687b-dcaf-928c-e053-6294a90a6abe	2025-10-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	90ccb29c-9967-46cb-a409-e440344e1a1a	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Childrens Honey Day Night DM Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	f9999875-3433-4052-a628-39539d373216	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief Value Pack	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Haleon US Holdings LLC	4029eccd-5443-4ae2-9232-2a1d922798f8	2025-10-15	Warnings	Exact identifier application number: M012
EndaCof DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	c68ea55a-8b9a-4a70-8b5c-1a2736651813	2025-10-15	Warnings	Exact identifier application number: M012
DURATUSS DM	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	413a3951-d704-f14b-e063-6394a90a06dc	2025-10-15	Warnings	Exact identifier application number: M012
LoHist DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	29730dab-fa09-4351-9b36-0359ba4f7744	2025-10-15	Warnings	Exact identifier application number: M012
M-END DMX	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	R. A. McNeil Company	ee1fae2e-3a21-4487-9989-c7620a4a7056	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Tuss	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	R.A. McNeil Company	43610aaa-8b94-40d5-ae09-3d75bd2317c8	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Hist	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE	R. A. McNeil Company	d046f4ba-5753-4ed5-a924-0b66fd116781	2025-10-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	6ca7372b-50c4-4b15-b133-fefa35525ade	2025-10-15	Warnings	Exact identifier application number: M012
Extra Strength Sinus Relief Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	0d8a009c-30b5-4f12-90bd-f8aa1110243f	2025-10-14	Warnings	Exact identifier application number: M012
Tussin DM Cough plus Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Cardinal Health 110, Inc. DBA LEADER	9d11f443-c93d-44e8-b5a3-2677b7b11212	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho SF	GUAIFENESIN	Efficient Laboratories, Inc.	31ff48fc-9603-413c-ab7c-2598b3e08f9c	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	d108c712-bc36-41d7-9ccd-720496b5599e	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pechito DM for Kids	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	004d12e1-6e3d-84c8-e063-6394a90aa653	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF CP Allergy / Cough	CHLOPHEDIANOL HCL, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	0bdea30a-39da-6611-e063-6394a90aa4cf	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	cf3886ab-62b3-497a-a587-18cbfbaf3634	2025-10-14	Warnings	Exact identifier application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	42d4bafb-b630-487e-b63d-13ad37a59454	2025-10-14	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	410c19f7-213d-cd99-e063-6294a90af5a3	2025-10-13	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