oxymetazoline hydrochloride

Product NDC: 68071-3422
11-digit product format: 680713422
Labeler code: 68071
Product ID: 68071-3422_36b1caf3-8f0e-088c-e063-6394a90a6a07
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-12-05
Marketing end: 2027-02-28
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
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 · 6 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
2025-02-02 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	68071-3422-1	`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	68071-3422-1	`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	68071-3422-1	`0efc9e666f02…`	`f202fb6c5f17…`

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: oxymetazoline hydrochloride

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
fd058e2b-5445-e416-e053-6394a90a611b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3422-1	2025-03-04	C162847	48780-1	2cef2736-8f70-d83d-e063-dadaa90ab31f	Perrigo Oxymetazoline HCl 0.05% Drug Facts
68071-3422-1	2025-01-30	C162847	48780-1	2cef2736-8f70-d83d-e063-dadaa90ab31f	Perrigo Oxymetazoline HCl 0.05% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3422-1	oxymetazoline hydrochloride	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		3
68071-3422-1	oxymetazoline hydrochloride	1 in 1 CARTON	SPRAY	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3422	OXYMETAZOLINE HYDROCHLORIDE SPRAY [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20250306_fd058e2b-5445-e416-e053-6394a90a611b.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 40 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb	2026-04-09	Warnings	Exact identifier application number: M012
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	e20b1093-d77f-4c39-b105-adaa1b82ea76	2026-04-09	Warnings	Exact identifier application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	4f0c1b8e-3fb1-ccf2-e063-6394a90acd15	2026-04-09	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Lidl US LLC	b26ac105-f8e4-4ad0-8a26-9fdf30c01700	2026-04-09	Warnings	Exact identifier application number: M012
Wal Dryl Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	09de28cd-fa60-4af7-b7cc-cf74c00a3531	2026-04-09	Warnings	Exact identifier application number: M012
Tussin DM Max NIGHTTIME	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	d10a413e-22a6-4799-8367-5777831756a9	2026-04-09	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	80d25e23-b108-4eb1-88c7-73fe9da8f942	2026-04-09	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough	DEXTROMETHORPHAN HBR AND GUAIFENESIN	L.N.K. International, Inc.	2fea3533-8218-4875-affe-5b33a22c553a	2026-04-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Plus Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Kenvue Brands LLC	4e60e1ad-4ad4-c329-e063-6294a90ab318	2026-04-08	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4592d547-556f-4eec-8faf-6ff9a92e46c8	2026-04-08	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	e24121d2-c9d2-4bbd-869e-eeed7e2bb881	2026-04-08	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	8460d4f9-8d7b-4ae4-8047-c2010d9c8013	2026-04-08	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	d2dab450-cf82-4be2-a4e2-630295fb59ab	2026-04-08	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	4657c02b-887b-4746-8a78-83a72465e07b	2026-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	33646fab-79a5-4f10-8ac0-48423eac9b56	2026-04-07	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	76e19b9a-3bdb-479a-9503-9e8250109c84	2026-04-07	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	7959ea00-2a41-4c3c-8c58-85795ebd2afc	2026-04-06	Warnings	Exact identifier application number: M012
dimaphen dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Preferred Pharmaceuticals Inc.	da148c1d-e394-4367-83e0-533469501b30	2026-04-06	Warnings	Exact identifier application number: M012
Cough Relief Adult	DEXTROMETHORPHAN HBR	TOP CARE (Topco Associates LLC)	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	2026-04-06	Warnings	Exact identifier application number: M012
Allergy Plus Sinus Relief	DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	Rite Aid Corporation	54623e2e-5f9a-426e-8f7e-ea755ff8b3f8	2026-04-06	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	fd058e2b-5445-e416-e053-6394a90a611b	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	fd058e2b-5445-e416-e053-6394a90a611b	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	fd058e2b-5445-e416-e053-6394a90a611b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3422-1	68071342201	1 BOTTLE, SPRAY in 1 CARTON (68071-3422-1) / 30 mL in 1 BOTTLE, SPRAY	2023-05-31	2027-02-28	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Oxymetazoline HCl 0.05% Drug Facts	NuCare Pharmaceuticals,Inc.	2025-06-03	HUMAN OTC DRUG LABEL	3