FDA.reportPublic FDA data

CareOne Nasal and Sinus Decongestant

Product NDC
41520-881
11-digit product format
415200881
Labeler code
41520
Product ID
41520-881_76d916fd-fd92-4398-b2c1-ad8c0ffd7a68
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-25
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-88141520-881-67DDiscontinued by firm2026-10-23

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 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
CareOne Nasal and Sinus Decongestant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81b31070-9b03-4ce4-8aac-a334544842aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-881-62CareOne Nasal and Sinus Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED123
41520-881-62CareOne Nasal and Sinus Decongestant2 in 1 CARTONTABLET, FILM COATED23
41520-881-67CareOne Nasal and Sinus Decongestant4 in 1 CARTONTABLET, FILM COATED43
41520-881-67CareOne Nasal and Sinus Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED123
41520-881-80CareOne Nasal and Sinus Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED123
41520-881-80CareOne Nasal and Sinus Decongestant8 in 1 CARTONTABLET, FILM COATED83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-881CAREONE NASAL AND SINUS DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 6 package rows20241003_81b31070-9b03-4ce4-8aac-a334544842ae.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 96 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapor StickCAMPHOR/MENTHOLRejoice International Corp.33d1fbf3-d33c-58b9-e063-6294a90ae0982025-10-13WarningsExact identifier
application number: M012
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCdb81e32b-0cad-400b-8479-a3b51de92b122025-10-10WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852ceea2-d6a1-6de2-e053-2a91aa0ad50d2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
application number: M012
Giltuss Diabetic Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
application number: M012
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
application number: M012
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8b2c847-25e9-8714-e053-2995a90a73ce2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c5027f-9701-fb07-e053-2a95a90a60292025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8c052d8-fb9f-09f2-e053-2a95a90a37af2025-10-09WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINGil Pharmaceutical Corpa8c53c14-ba82-2c68-e053-2a95a90a98942025-10-09WarningsExact identifier
application number: M012
Giltuss Severe SinusOXYMETAZOLINE HCLGil Pharmaceutical Corpab7fae3b-1f7d-5d0f-e053-2a95a90a148e2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c08532-1169-6603-e053-2a95a90a34842025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINGil Pharmaceutical Corpa8c59e6d-c11c-2664-e053-2a95a90a83332025-10-09WarningsExact identifier
application number: M012
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN81b31070-9b03-4ce4-8aac-a334544842ae3
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD81b31070-9b03-4ce4-8aac-a334544842ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-881-62415200881622 BLISTER PACK in 1 CARTON (41520-881-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2017-09-250000-00-00NoNoCurrent
41520-881-67415200881674 BLISTER PACK in 1 CARTON (41520-881-67) > 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2017-09-250000-00-00NoNoCurrent
41520-881-80415200881808 BLISTER PACK in 1 CARTON (41520-881-80) / 12 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2017-09-250000-00-00NoNoCurrent