oxymetazoline hcl

Product NDC: 45802-410
11-digit product format: 458020410
Labeler code: 45802
Product ID: 45802-410_999f909c-4119-4f4e-9093-6438801b878d
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Padagis Israel Pharmaceuticals Ltd
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

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 hcl

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
a1103cd8-344b-4a65-8a60-3c7be86d01a6	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
45802-410-59	oxymetazoline hcl	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		7
45802-410-59	oxymetazoline hcl	1 in 1 CARTON	SPRAY	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-410-59	ML - Milliliter	45802-410	54e747ad-1a30-4db2-8182-ca670b35ec25	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-410	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]	7	Current NDC, Legacy NDC, 2 package rows	20240912_a1103cd8-344b-4a65-8a60-3c7be86d01a6.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 164 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG	RITE AID	c92dbbbb-d149-1e7e-e053-2a95a90a6f1a	2024-04-17	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG	RITE AID	c9323799-3505-d6c1-e053-2995a90a6f43	2024-04-17	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fac8b01a-9666-43cc-a4ff-3f3ed452c7e4	2024-04-17	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	P & L Development, LLC	15e9a336-1b34-4f00-9d1c-b945ddf17ed9	2024-04-16	Warnings	Exact identifier application number: M012
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	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	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
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
45802-410-59	45802041059	1 BOTTLE, SPRAY in 1 CARTON (45802-410-59) / 30 mL in 1 BOTTLE, SPRAY	2005-12-05	2027-02-28	No	No	Current

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
Oxymetazoline HCl 0.05% Drug Facts	A-S Medication Solutions	2024-11-06	HUMAN OTC DRUG LABEL	8
Oxymetazoline HCl 0.05% Drug Facts	Padagis Israel Pharmaceuticals Ltd	2024-09-11	HUMAN OTC DRUG LABEL	7