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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-30441520-304-72DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…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
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0c35e06-c9e9-438e-8224-d4760b6e2affAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-304-10care one nasaloriginal30 mL in 1 BOTTLE, SPRAYSPRAY308
41520-304-10care one nasaloriginal1 in 1 CARTONSPRAY18
41520-304-72care one nasaloriginal1 in 1 CARTONSPRAY18
41520-304-72care one nasaloriginal37 mL in 1 BOTTLE, SPRAYSPRAY378

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RCARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-304CARE ONE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [AMERICAN SALES COMPANY]8Current NDC, Legacy NDC, 4 package rows20241110_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 46 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and NighttimeACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP43da4211-3bb3-0a8e-e063-6294a90a4fcd2026-03-16WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLKroger Companyab12c975-2085-4365-9c4b-0be573a260c42026-03-13WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC88e3e51a-c9a5-43f9-b9d7-97509c607df12026-03-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCLRB Health (US) LLC4cc490a6-a27a-a25b-e063-6294a90a3a952026-03-11WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCba6d69ff-b392-4f21-b3d7-00d8ec5dee322026-03-11WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEB40091b98-b4c7-4a3b-e063-6294a90abd5d2026-03-10WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEUnited Natural Foods, Inc. dba UNFI0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATETopco Associates, LLC35305aa9-4fc1-4cda-b6f0-89df64f9eeff2026-03-10WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway03332596-2c37-4771-b13b-ab766e6168662026-03-10WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief Maximum StrengthPSEUDOEPHEDRINE HCLRite Aid Corporationd86140ab-1117-4d14-a380-f5cc375775a12026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN4c9cca86-41bf-1635-e063-6294a90a17fb2026-03-09WarningsExact identifier
application number: M012
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.447a8753-96bd-676a-e063-6394a90a48f22026-03-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa0c35e06-c9e9-438e-8224-d4760b6e2aff8
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa0c35e06-c9e9-438e-8224-d4760b6e2aff8
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa0c35e06-c9e9-438e-8224-d4760b6e2aff8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41520-304-10415200304101 BOTTLE, SPRAY in 1 CARTON (41520-304-10) / 30 mL in 1 BOTTLE, SPRAY2004-05-240000-00-00NoNoCurrent
41520-304-72415200304721 BOTTLE, SPRAY in 1 CARTON (41520-304-72) > 37 mL in 1 BOTTLE, SPRAY2005-03-290000-00-00NoNoCurrent