nasal

Product NDC: 42507-304
11-digit product format: 425070304
Labeler code: 42507
Product ID: 42507-304_bc9e7412-d42c-4be3-a234-52e06b94c67d
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: 1991-11-18
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42507-304	42507-304-72	D	Discontinued by firm		2026-10-15

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 · 36 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	42507-304-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-304-72	`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	42507-304-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-304-72	`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	42507-304-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-304-72	`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	42507-304-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-304-72	`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	42507-304-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-304-72	`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	42507-304-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-304-72	`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	42507-304-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-304-72	`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	42507-304-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-304-72	`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	42507-304-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-304-72	`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	42507-304-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-304-72	`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	42507-304-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-304-72	`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	42507-304-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-304-72	`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
Brand name suffix: original
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
d997f264-1b4a-4cca-a282-bd9645d55bfd	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42507-304-10	nasaloriginal	1 in 1 CARTON	SPRAY	1	6
42507-304-30	nasaloriginal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	6
42507-304-72	nasaloriginal	1 in 1 CARTON	SPRAY	1	6
42507-304-72	nasaloriginal	37 mL in 1 BOTTLE, SPRAY	SPRAY	37	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [HYVEE INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) 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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	d997f264-1b4a-4cca-a282-bd9645d55bfd	6
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	d997f264-1b4a-4cca-a282-bd9645d55bfd	6
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	d997f264-1b4a-4cca-a282-bd9645d55bfd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-304-10	42507030410	1 BOTTLE, SPRAY in 1 CARTON (42507-304-10) / 30 mL in 1 BOTTLE, SPRAY (42507-304-30)		1991-11-18	No	No	Current
42507-304-30	42507030430	30 mL in 1 BOTTLE, SPRAY	30 ml				Historical
42507-304-72	42507030472	1 in 1 CARTON					Historical