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		2026-10-15

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 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4	2026-05-08	Warnings	Exact identifier application number: M012
day time non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	f4fd597f-bca2-4ed4-b353-6c734f2f885c	2026-05-08	Warnings	Exact identifier application number: M012
Daytime Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	d8339bb0-5da3-4f34-a819-339643cf4a97	2026-05-08	Warnings	Exact identifier application number: M012
severe tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	a26afc33-533e-4dc0-ab25-21be87356e22	2026-05-08	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	cdd53eba-1fa2-49c1-b03d-c32f309da7fb	2026-05-08	Warnings	Exact identifier application number: M012
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	H E B	6503761f-37ae-4f39-b727-cb75d4c4a3c9	2026-05-07	Warnings, Adverse reactions	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	ad199488-a4be-4b6e-b806-67ce8a6e907e	2026-05-07	Warnings	Exact identifier application number: M012
good sense nasal	OXYMETAZOLINE HCL	L. Perrigo Company	5d42adb9-3625-4072-a6b1-29a229f255c8	2026-05-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	4856cd7b-ccdf-4546-9c65-236ebaac3dca	2026-05-06	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac	2026-05-06	Warnings	Exact identifier application number: M012
daytime cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	175cc2d0-0202-4e38-8af2-9fc126b7412d	2026-05-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	90fae0fa-da07-4ea8-bdbd-39c2ed99ae59	2026-05-06	Warnings	Exact identifier application number: M012
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	5d8b980f-0011-41e3-a881-ad10fe399079	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	38d12374-e2c7-444c-e063-6294a90a42b3	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	1ab295ff-94b1-c938-e063-6294a90a98fd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	512af63d-2f09-4baa-e063-6394a90a86bd	2026-05-06	Warnings	Exact identifier application number: M012
Thieves Chest Rub	CHEST RUB	Young Living Essential Oils, LC.	9b7f125e-6caa-c53e-e053-2a95a90a737e	2026-05-06	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Plus Pain and Headache	ACETAMINOPHEN, GUAIFENESIN	Shield Pharmaceuticals Corp	f20c0db1-dcf3-4bfc-b3e4-930398f82dc9	2026-05-06	Warnings	Exact identifier application number: M012
Nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	8aa6492b-1723-4c6b-82ee-4f800301c6ad	2026-05-06	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