OXYMETAZOLINE HYDROCHLORIDE

Product NDC: 63868-607
11-digit product format: 638680607
Labeler code: 63868
Product ID: 63868-607_b20bf193-c444-44c8-8fea-012de3f835f4
Type: HUMAN OTC DRUG
Nonproprietary name: OXYMETAZOLINE HYDROCHLORIDE
Dosage form: SPRAY
Route: NASAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-02-01
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

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
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
2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	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	Strength	SPL version
63868-607-01	OXYMETAZOLINE HYDROCHLORIDE	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-607	OXYMETAZOLINE HYDROCHLORIDE SPRAY [CHAIN DRUG MARKETING ASSOCIATION INC.]	2	Current NDC, 1 package rows	20241228_2ee2b332-9b85-45a6-b242-3f0ebfbd08a6.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 127 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Harris Teeter Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	4ebe1d94-bb15-4250-a4c2-8cd45743c7dd	2024-12-18	Warnings	Exact identifier application number: M012
Care One Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	RETAIL BUSINESS SERVICES , LLC	f6657dee-9f32-45b1-8e44-1ad67a4a68bd	2024-12-18	Warnings	Exact identifier application number: M012
Childrens Metapp Daytime	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Guardian Drug Company	40565500-944b-47f2-8563-5df05469e418	2024-12-18	Warnings	Exact identifier application number: M012
CVS Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	CVS Pharmacy, Inc.	884abed2-e355-4134-92f1-591f3a18f71d	2024-12-18	Warnings	Exact identifier application number: M012
CVS Health Chest Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	CVS Pharmacy, Inc.	a49020e8-739e-47ec-8141-e866479a3ab3	2024-12-18	Warnings	Exact identifier application number: M012
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	AmerisourceBergen Drug Corp	79cefd46-bd19-4a1d-9cb1-e85ff0f12494	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Cardinal Health	8397e1b9-e83e-4c6a-b858-1663c2365840	2024-12-18	Warnings	Exact identifier application number: M012
GNP Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	AmerisourceBergen Drug Corp	63932e68-b09d-4500-bc1d-cfb2c267df1c	2024-12-18	Warnings	Exact identifier application number: M012
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Exact identifier application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	TOPCO ASSOCIATES LLC	b6c0362f-86ca-4f08-ba53-800c6df2c025	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	10cad9a7-1223-470c-9027-807891217d40	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Rugby Laboratories	5da36516-9f94-49cb-9421-0c310abcd116	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	THE KROGER CO	430c6604-93a7-4df6-a657-ba438aa61425	2024-12-18	Warnings	Exact identifier application number: M012
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	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	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63868-607-01	63868060701	30 mL in 1 BOTTLE, SPRAY (63868-607-01)	30 ml	2021-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Original Nasal Spray Congestion Relief	CHAIN DRUG MARKETING ASSOCIATION INC. \| Seaway Pharma Inc.	2024-12-26	HUMAN OTC DRUG LABEL	2