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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold Cough and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	a35531d7-1a96-45cb-922f-61db085cde1f	2026-06-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	5fe9f313-d6e7-41f5-abfc-e4c72b708961	2026-06-15	Warnings	Exact identifier application number: M012
Pain Relief Sinus Congestion	ACETAMINOPHEN, PHENYLEPHRINE HCL	Better Living Brands, LLC	1d3d6397-0d92-4145-9a70-8bcc45bd0322	2026-06-15	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d5d9334d-3db6-4f45-ab84-3e1ec5a752c6	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Geiss, Destin & Dunn Inc.	fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b	2026-06-15	Warnings	Exact identifier application number: M012
equate daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	983a4783-d826-41b6-8087-ca66bcd5b6ca	2026-06-12	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	4173ecde-a2d7-4836-a6e9-fef2270d1b4e	2026-06-12	Warnings	Exact identifier application number: M012
PAIN RELIEVER PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	cf370a59-42d5-42fe-882f-09885c55f570	2026-06-11	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion Plus Cold Severe Day	ACETAMINOPHEN, PSEUDOEPHEDRINE	Kenvue Brands LLC	537e1a0d-820d-c3f7-e063-6294a90a56ea	2026-06-10	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and Night	ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE	Kenvue Brands LLC	5382dcad-0337-4440-e063-6394a90a706e	2026-06-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	21cfa71c-7a8f-4100-a42e-9190260653d1	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	WALGREENS	47f1d92f-cb4b-1635-e063-6294a90a2c71	2026-06-09	Warnings	Exact identifier application number: M012
HALLS Honey	MENTHOL	Mondelez Global LLC	837f5ded-8efb-402b-a1bc-b5c142755660	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	932b11b1-f4a0-417a-bfa1-05261a172155	2026-06-08	Warnings	Exact identifier application number: M012
NO DRIP NASAL MIST	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	957efbcf-b6d3-4793-bb6e-27e99c9be905	2026-06-08	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	493caecb-e687-49ea-b7a1-2a5b9376896d	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	4ad10fd7-c088-4356-9d34-a95cfe3a4133	2026-06-08	Warnings	Exact identifier application number: M012
Theraflu Severe Congestion Relief Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	4ec42064-7390-4137-a93e-57343c3c76a7	2026-06-08	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