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 167 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	62f7fcb9-e31a-4634-b1c2-44a9567e3a61	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Caplets	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	8e22f6bc-33ce-4bb0-99be-7947aa21f60e	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Syrup	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	777d2ac7-e3cc-4513-8b6f-b90b2ff2c672	2024-03-07	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	4c6025ff-4982-4408-b077-75dd5f5b65b2	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	423fd5e6-5d90-4539-81e0-0ae23881ee3a	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	917df706-1982-4240-9f56-42d426b76cc5	2024-03-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	21a29998-29d6-4a36-a370-291d23bfb197	2024-03-05	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	3c7ef3cf-f7f9-42bc-bf20-e36954b9671f	2024-03-05	Warnings	Exact identifier application number: M012
QUALITY CHOICE NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	da06e994-6848-4c1e-9432-31de5e626ea4	2024-03-02	Warnings	Exact identifier application number: M012
QUALITY CHOICE DayTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	417c4fa9-6458-40d0-b22a-2415194e250f	2024-03-02	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Aurohealth LLC	8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2	2024-03-01	Warnings	Exact identifier application number: M012
APRODINE	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	A-S Medication Solutions	bbc268b8-fa66-4dc5-b935-f77ae39d28c8	2024-02-29	Warnings	Exact identifier application number: M012
XtraCare Vaporizing Chest Rub	CAMPHOR, MENTHOL	Rejoice International	c3e220d6-fff4-452f-99a9-bd701fc608a0	2024-02-28	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	ebbb2f4b-ba84-40ad-96f6-60225119a33b	2024-02-27	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	1c93c45d-1141-4599-83ba-6d3b38f9ffc4	2024-02-23	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