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 153 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Dabur India Limited	22916978-303d-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M012
Topcare Nasal Decongestant Maximum Strength Non Drowsy	PSEUDOEPHEDRINE HCL	Topco Associates LLC	1a9e0336-c0c2-43f8-aeea-668d4a209714	2024-09-20	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	25609b66-047c-46e7-bc95-20eb8e6c9617	2024-09-20	Warnings	Exact identifier application number: M012
equaline nasal	PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	67fdd277-7a7a-4404-8ca2-39802c46405f	2024-09-20	Warnings	Exact identifier application number: M012
equaline tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	8bc7fa7c-d565-48c9-9808-1042c3e9d428	2024-09-20	Warnings	Exact identifier application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	d7fae410-9c1c-4231-9fde-2c51ad3d7e95	2024-09-20	Warnings	Exact identifier application number: M012
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Exact identifier application number: M012
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	89272d2d-5533-4ae8-865b-cb204cec6d65	2024-09-17	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	5791c1c7-f614-4940-a45a-6291742e1e22	2024-09-17	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	2affd44d-2125-4a1f-919c-c082e7644ea8	2024-09-17	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE	Advanced Rx LLC	fa1a4d86-87bb-0c50-e053-6394a90a56e2	2024-09-13	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Advanced Rx LLC	fa1b60b1-49cb-1211-e053-6394a90a0a46	2024-09-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	8db7df1c-46b5-49bd-9002-50b12d58001a	2024-09-13	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1bdd7f8a-93ce-5309-e063-6294a90a91f0	2024-09-12	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