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 131 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	db2ab9be-507d-4768-9d00-188f751b7726	2024-12-10	Warnings	Exact identifier application number: M012
Adult Allergy Relief	CALMCO ALLERGY RELIEF	CalmCo	08288825-0f38-b6a3-e063-6394a90aa358	2024-12-07	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola Ag	c142663f-086e-4ab7-a758-9107d7077537	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	984c9793-163c-4b97-b244-9b471966a122	2024-12-05	Warnings	Exact identifier application number: M012
BENZEDREX	PROPYLHEXEDRINE	BF ASCHER AND CO INC	00d8c237-3eee-1d9f-e063-6394a90aeb86	2024-12-05	Warnings	Exact identifier application number: M012
Cold Multi Symptom Daytime Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	d5cbb5b0-564c-429e-b680-fa683e796393	2024-12-05	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	de8a623f-7b10-4d56-a74b-3737e7716ffe	2024-12-05	Warnings	Exact identifier application number: M012
Cold Max Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	9773958b-c5e5-4da7-a8e9-6b6c223a2b30	2024-12-05	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	399e0e51-c2a7-451c-b74d-d3db140cef69	2024-12-05	Warnings	Exact identifier application number: M012
Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	09531edc-8dbd-451f-ae02-f922e9e8c248	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	71ca8af7-172d-40da-be1e-ff3ab5568e74	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	b790a91c-33be-4bc3-bdeb-eae6f366f085	2024-12-05	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola Ag	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola Ag	8b2d5c0f-509e-447d-b071-d73c4785f120	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	8ae0e21a-44a0-4a2c-9880-54eeeaea07ea	2024-12-05	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	6d82469b-d51c-4824-9830-6c1874ad4fe4	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola Ag	e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	a535717d-ba55-45e9-9fc3-711b5d7dbf57	2024-12-05	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola Ag	4330ee8d-0b37-4a93-886b-5fc6e6598da7	2024-12-05	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORP	9de99931-31ef-79e2-e053-2a95a90a98ad	2024-12-04	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