Oxymetazoline Hydrochloride

Product NDC: 51672-2030
11-digit product format: 516722030
Labeler code: 51672
Product ID: 51672-2030_56bb5577-e3d4-ae0b-e063-6394a90ab52c
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-02-25
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
Brand name suffix: 12-Hour
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
34a79f8b-32b7-48db-a895-c942cc795292	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2030-3	Oxymetazoline Hydrochloride12-Hour	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	3
51672-2030-3	Oxymetazoline Hydrochloride12-Hour	1 in 1 CARTON	SPRAY	1	3
51672-2030-5	Oxymetazoline Hydrochloride12-Hour	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	3
51672-2030-5	Oxymetazoline Hydrochloride12-Hour	1 in 1 CARTON	SPRAY	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2030-3	ML - Milliliter	51672-2030	6438d50f-2bf2-4061-a793-5d3f37fb4b61	1	2012-07-24
51672-2030-5	ML - Milliliter	51672-2030	50c5526b-5725-4806-b309-7c4fdb3242e8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
POLYETHYLENE GLYCOL 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	2
Oxymetazoline Hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
polyethylene glycol 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	22ADO53M6F	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium phosphate, monobasic, monohydrate	INACTIVE INGREDIENT	593YOG76RN	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2030	OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 4 package rows	20250316_34a79f8b-32b7-48db-a895-c942cc795292.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 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80cad8d-da4c-049d-e053-2a95a90ac20e	2024-12-18	Warnings	Exact identifier application number: M012
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	8a97c012-6a47-4607-9389-58a4eed17b08	2024-12-18	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Orazen Inc	ecddaa3b-e18f-1c74-e053-2995a90ad86a	2024-12-18	Warnings	Exact identifier application number: M012
Rite Aid Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Rite Aid	dfedbef1-8062-432d-e053-2a95a90a09e9	2024-12-18	Warnings	Exact identifier application number: M012
TheraCare Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	f7801843-f96c-710e-e053-6294a90a5086	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief G450	GUAIFENESIN	Rugby Laboratories	a6aa8cbd-21ff-4f84-b338-c05c2d46e6df	2024-12-18	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	861dffb7-8bf4-4f03-bcc2-ed8a35bc341d	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Marc Glassman Inc	be3ad54f-522c-440d-b8c7-9664f6015566	2024-12-18	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	2024-12-18	Warnings	Exact identifier application number: M012
Family Wellness Chest Congestion Relief	GUAIFENESIN	Family Dollar Services Inc	412f3459-4c22-4822-86bd-011fc3e91ca6	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Mucus Relief	GUAIFENESIN	Marc Glassman Inc	455b9f01-206c-4534-a006-292d2bd48f47	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief G450	GUAIFENESIN	Cardinal Health	4586a83f-077c-4fb3-adfe-7a9497a78d97	2024-12-18	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	5372f764-985e-4a42-bc97-cb0dc90fcd9c	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion and Cough Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	TOPCO ASSOCIATES LLC	5a2d0464-038d-4c3f-b39e-ee9984fb383e	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Valu Merch	a72b6a97-f97f-44bb-8d55-ac48b8ba45c5	2024-12-18	Warnings	Exact identifier application number: M012
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

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	34a79f8b-32b7-48db-a895-c942cc795292	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	34a79f8b-32b7-48db-a895-c942cc795292	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	34a79f8b-32b7-48db-a895-c942cc795292	3
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	dd196e5a-a791-47ad-aab5-3f2e760f758a	2
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	dd196e5a-a791-47ad-aab5-3f2e760f758a	2
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	dd196e5a-a791-47ad-aab5-3f2e760f758a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2030-3	51672203003	1 BOTTLE, SPRAY in 1 CARTON (51672-2030-3) / 30 mL in 1 BOTTLE, SPRAY	2006-02-25	0000-00-00	No	No	Current
51672-2030-5	51672203005	1 BOTTLE, SPRAY in 1 CARTON (51672-2030-5) / 15 mL in 1 BOTTLE, SPRAY	2006-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxymetazoline Hydrochloride Nasal Decongestant 12-Hour Spray	Sun Pharmaceutical Industries, Inc. \| Applied Laboratories, Inc.	2026-07-16	HUMAN OTC DRUG LABEL	4
Nasal Decongestant Drug Facts	Rebel Distributors Corp	2011-02-21	HUMAN OTC DRUG LABEL	2