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		2026-10-20

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 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens Allergy Dye Free Wal Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	4e64e040-1662-4dc9-b33f-3e119e0b3f7b	2025-11-25	Warnings	Exact identifier application number: M012
Walgreen	NASAL	WALGREENS CO	d38f8406-d7b9-472c-a472-58968bbdb993	2025-11-25	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	780907b8-34ba-4ec8-bcdf-b2a31bd111df	2025-11-25	Warnings	Exact identifier application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	d13efbcd-1277-45d0-8389-1ba0337f7a24	2025-11-25	Warnings	Exact identifier application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	fe903448-b422-42e0-b05b-aeb3e5481e3c	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	1d4fcb76-22d1-7292-e063-6394a90af920	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	f22248b7-7abd-4df7-a986-dae357ebe8f1	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	39468746-e06d-4849-9d06-9af4d14351b0	2025-11-25	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Grocery Outlet, Inc.	4478fd51-bae3-6108-e063-6394a90a07ca	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	395bb39a-e26f-f4f2-e063-6394a90ae721	2025-11-25	Warnings	Exact identifier application number: M012
day time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	eaf3af6a-de5b-43fe-83ff-9641646e0f6b	2025-11-25	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	RB Health (US) LLC	38571853-992f-9998-e063-6394a90a8581	2025-11-24	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	e19b561c-fb76-4355-a306-d3dc46930bf2	2025-11-24	Warnings	Exact identifier application number: M012
Sinus Decongestion	PSEUDOEPHEDRINE HCL	Kroger Company	73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c	2025-11-24	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Cardinal Health (Leader) 70000	14c507df-fbac-4a09-a66c-b91c2abbf550	2025-11-24	Warnings	Exact identifier application number: M012
Severe Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI	Family Dollar (FAMILY WELLNESS)	e5c90d6e-70aa-4886-bc81-293e0dcf5638	2025-11-24	Warnings	Exact identifier application number: M012
Throat Coat Eucalyptus Mint	MENTHOL	Traditional Medicinals, Inc.	a7a86f1b-30e8-6f5d-e053-2a95a90a2a82	2025-11-21	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	4538248f-11cc-d6b2-e063-6294a90a652c	2025-11-21	Warnings	Exact identifier application number: M012
up and up Daytime Nighttime Childrens Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7	2025-11-20	Warnings	Exact identifier application number: M012
Supress DX Pediatric Drops	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	ddb95436-7806-4086-af4d-18a6625b5c83	2025-11-20	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