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: 2027-12-31
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		2026-10-23

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: 2027-12-31

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 159 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	4c6b6379-3a7f-4507-a792-7b69a7f3ba82	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	04defcf6-e20e-402b-b725-d9394a0146b1	2024-07-16	Warnings	Exact identifier application number: M012
basic care allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	7d237d37-21c7-476d-a8b7-d91ea1b472ee	2024-07-16	Warnings	Exact identifier application number: M012
Berkley and Jensen Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC	b52fc311-8853-4116-941b-8be35456abba	2024-07-16	Warnings	Exact identifier application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	0b9a4438-7d13-484c-a614-2dedc24974dc	2024-07-16	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Publix Super Markets Inc	23a98385-28cc-4fac-8c87-b3ced8106532	2024-07-16	Warnings	Exact identifier application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe	0.05% OXYMETAZOLINE	Walgreens Company	aad01028-cbe0-4c10-adbc-d157bfa5af09	2024-07-16	Warnings	Exact identifier application number: M012
Basic Care severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	924bf427-b054-46af-b341-ff162946cd58	2024-07-15	Warnings	Exact identifier application number: M012
Maximum Strength Cold Tabs	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	JHK DBA American Safety & First Aid	e7d4fe9a-eb09-4266-90c9-290f61ce6ad0	2024-07-15	Warnings	Exact identifier application number: M012
ACTIDOM DA	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2024-07-15	Warnings	Exact identifier application number: M012
Nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1cf3064d-4ddd-63b9-e063-6294a90aa547	2024-07-11	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	TARGET CORPORATION	1ccbdb53-3f70-28da-e063-6394a90a9ae0	2024-07-09	Warnings	Exact identifier application number: M012
AXIV Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1cd2a6f1-31ad-e507-e063-6394a90aba58	2024-07-09	Warnings	Exact identifier application number: M012
Poly Hist Forte	DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aa0015b-8fc1-7951-e053-2a95a90a8e72	2024-07-09	Warnings	Exact identifier application number: M012
DECONEX DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aab8e5c-1633-2e5a-e053-2a95a90adcc5	2024-07-09	Warnings	Exact identifier application number: M012
Deconex IR	GUAIFENESIN AND PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	4710095e-3dae-4a39-8a98-873012e1f003	2024-07-09	Warnings	Exact identifier application number: M012
Diabetic Tussin Sore Throat and Cough Cherry	BENZOCAINE AND DEXTROMETHORPHAN HBR	MEDTECH PRODUCTS INC	e9327079-e0fc-4c95-b1d5-bc1b74870c9b	2024-07-09	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	fac859a4-e23a-4879-af6c-26368455506d	2024-07-05	Warnings	Exact identifier application number: M012
Severe Throat Drops	MENTHOL ICE	Target Corporation Inc.	1876b221-fa60-5269-e063-6394a90a6963	2024-07-04	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	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