Major Nasal Decongestant

Product NDC: 0904-7435
11-digit product format: 009047435
Labeler code: 0904
Product ID: 0904-7435_22987538-bbaf-4dce-ba33-325abacdec70
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-31
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .5 mg/mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Major Nasal Decongestant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.5 mg/mL

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
edb49b17-06a7-4c25-bc7c-d62c1deac7f1	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	Strength	SPL version
0904-7435-35	Major Nasal Decongestant	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		2
0904-7435-35	Major Nasal Decongestant	1 in 1 CARTON	SPRAY	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7435-35	ML - Milliliter	0904-7435	955eff39-c5c2-4214-995a-2f1239c48596	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7435	MAJOR NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]	2	Current NDC, 2 package rows	20231231_edb49b17-06a7-4c25-bc7c-d62c1deac7f1.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 163 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	dbfb8971-a122-4a97-a665-e3f0d494876e	2024-05-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012
NASAL and SINUS DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	JHK Inc dba American Safety & First Aid	63e51305-2575-49c4-9fda-7b3e1b4b6ede	2024-04-26	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Haleon US Holdings LLC	7decc168-e847-4bbe-910b-26081469406f	2024-04-26	Warnings	Exact identifier application number: M012
Severe cold and flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	P & L Development, LLC	7c92bdcf-db1f-4299-982f-6a3da9cba6e6	2024-04-25	Warnings	Exact identifier application number: M012
Severe cold and flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	P & L Development, LLC	15727e06-7bfc-424e-9e68-cc9cd5695bfd	2024-04-25	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	P & L Development, LLC	5872fed8-862b-44a2-a06e-51ebf8618271	2024-04-25	Warnings	Exact identifier application number: M012
CHERRY COUGH DROPS 50CT	MENTHOL, UNSPECIFIED FORM	JHK Inc dba American Safety & First Aid	2f54b9c1-3a37-48fd-b964-6aa2631b8e62	2024-04-24	Warnings	Exact identifier application number: M012
Dye Free Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	f1a33c2f-2330-43f3-8026-de21808aec66	2024-04-22	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	fc7954a6-d061-4160-b1d1-a19eb9eabff4	2024-04-22	Warnings	Exact identifier application number: M012
Dibromm Cold and Allergy Childrens	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	2024-04-22	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	c573da1e-c7ca-46e6-ad42-4ded2547afc3	2024-04-22	Warnings	Exact identifier application number: M012
Cough Relief Cough Suppressant	DEXTROMETHORPHAN HBR	QUALITY CHOICE (Chain Drug Marketing Association)	13ae4c67-a3fe-440c-91b8-c9412626c3cd	2024-04-22	Warnings	Exact identifier application number: M012
Pain Relief PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	47660794-22cc-4863-a183-e694d27e3543	2024-04-19	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	f9c08b18-a119-406b-bd96-73572b4445e2	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cough Relief	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e1fa0f51-6a68-4f6f-8988-0949d1942c2f	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	025f6622-a6db-4a5c-aebd-5d54172fa4a1	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	f9530d55-8226-4659-84f0-2c0b411572be	2024-04-17	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	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0904-7435-35	00904743535	1 BOTTLE, SPRAY in 1 CARTON (0904-7435-35) / 15 mL in 1 BOTTLE, SPRAY	2023-12-31	No	No	Current