care one nasal

Product NDC: 41520-304
11-digit product format: 415200304
Labeler code: 41520
Product ID: 41520-304_e8df6ac2-422f-4379-89e8-4346d645fd02
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: American Sales Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-05-24
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41520-304	41520-304-72	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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: care one nasal
Brand name suffix: original
Listing expiration: 2026-12-31

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
a0c35e06-c9e9-438e-8224-d4760b6e2aff	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	SPL version
41520-304-10	care one nasaloriginal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	8
41520-304-10	care one nasaloriginal	1 in 1 CARTON	SPRAY	1	8
41520-304-72	care one nasaloriginal	1 in 1 CARTON	SPRAY	1	8
41520-304-72	care one nasaloriginal	37 mL in 1 BOTTLE, SPRAY	SPRAY	37	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-304	CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]	8	Current NDC, Legacy NDC, 4 package rows	20241110_a0c35e06-c9e9-438e-8224-d4760b6e2aff.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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2	2026-08-10	Warnings	Exact identifier application number: M012
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a9f01760-e335-4410-a9b8-8edce2841270	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed	GUAIFENESIN	Aldama Pharmaceuticals, Inc	38f37272-2084-a33b-e063-6294a90ac150	2026-08-10	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate	CHLORPHENIRAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	7a3452a2-930f-48b1-8c59-dbceb10b9c78	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed DM	DEXTROMETHORPHAN, GUAIFENESIN	Aldama Pharmaceuticals, Inc	396bf716-0f61-9563-e063-6394a90a171b	2026-08-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	eff114fe-fb15-48dd-b673-4d4d66406e69	2026-08-10	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	651b03a3-b85e-4028-a9f2-472bec16c8f4	2026-08-10	Warnings	Exact identifier application number: M012
NASAL	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	02a89765-2a75-470a-9fd6-8cce71dc19e9	2026-08-10	Warnings	Exact identifier application number: M012
WINCO Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WINCO FOODS, LLC	f34bfb71-2c81-44d0-a2a0-4d320c43c217	2026-08-07	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	11cac20e-9bb6-4e2d-8efd-4451f055c7b4	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	1d02b32a-e88d-4c70-b66d-7bdc22c25a43	2026-08-07	Warnings	Exact identifier application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	c1ecc56b-8052-4b0a-900a-dc93a24771bd	2026-08-07	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	bbf7d296-fa3d-43e5-984c-e9d2881a074d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	WinCo Foods, LLC	790d534a-0f40-495b-a815-67851ac3d20d	2026-08-07	Warnings	Exact identifier application number: M012
Extra Moisturizing Nasal Pump Mist Anti Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	46ebd262-c6a4-43ea-a7f6-506561bb3de4	2026-08-07	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	WINCO FOODS, LLC	e6afa830-6ce2-4abc-b5c9-3f5f156444df	2026-08-07	Warnings	Exact identifier application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTH	ACETAMINOPHEN, PHENYLEPHRINE HCL	CVS Pharmacy	a3b073b4-494c-4531-b08e-475c86ba321d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WinCo Foods, LLC	dc56197c-c108-4b35-b791-dde5c3384ddd	2026-08-07	Warnings	Exact identifier application number: M012
Sinus Severe Non Drowsy, Daytime	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	84c30ec9-a7b5-4d2f-95b2-d6fb895945de	2026-08-07	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	887cabe5-46d0-4f4e-8f5a-2cfdbc157b58	2026-08-07	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	a0c35e06-c9e9-438e-8224-d4760b6e2aff	8
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	a0c35e06-c9e9-438e-8224-d4760b6e2aff	8
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	a0c35e06-c9e9-438e-8224-d4760b6e2aff	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-304-10	41520030410	1 BOTTLE, SPRAY in 1 CARTON (41520-304-10) / 30 mL in 1 BOTTLE, SPRAY	2004-05-24	0000-00-00	No	No	Current
41520-304-72	41520030472	1 BOTTLE, SPRAY in 1 CARTON (41520-304-72) > 37 mL in 1 BOTTLE, SPRAY	2005-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Original Nasal Spray Drug Facts	American Sales Company	2024-11-09	HUMAN OTC DRUG LABEL	8