FDA.reportPublic FDA data

CareOne DayTime Cold and Flu

Product NDC
41520-032
11-digit product format
415200032
Labeler code
41520
Product ID
41520-032_fc0e8ee7-2ced-445b-b7b0-ee6dee76e0dc
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-12
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 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 packagepackage41520-03241520-032-34DDiscontinued by firm2026-10-21

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 DayTime Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-032-34CareOne DayTime Cold and Flu237 mL in 1 BOTTLESOLUTION2375
41520-032-40CareOne DayTime Cold and Flu355 mL in 1 BOTTLESOLUTION3555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-032CAREONE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 2 package rows20240927_c4732df0-e760-4283-98f3-2d08c8cd6a9e.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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDeMoulas Market Baskete92d2f64-9690-42d3-b787-cafade3a89992023-12-29WarningsExact identifier
application number: M012
Cold and Sinus Maxium StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basket6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2023-12-29WarningsExact identifier
application number: M012
Cold, Flu and Sore Throat Maxium StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketd98029c0-ccd9-47e1-996f-c7786cd4ecca2023-12-29WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC0f2be061-bd0a-4e62-b994-6d0768ea647a2023-12-29WarningsExact identifier
application number: M012
Tussin CF Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketc19b9997-4037-48f3-b905-86da421a292d2023-12-29WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
application number: M012
Father Johns Cough Medicine PlusNASAL DECONGESTANTOakhurst Company8b8aab0f-251b-6bd8-e053-2995a90ad7482023-12-18WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBROakhurst Company8b8a249d-55af-cc98-e053-2995a90a431d2023-12-18WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79d92d2-d73c-d44f-e053-2995a90a03d92023-12-15WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBRHumco Holding Group, Inca7b0669f-8da1-5a44-e053-2995a90a84d92023-12-15WarningsExact identifier
application number: M012
Ephedrine HydrochlorideEPHEDRINE HYDROCHLORIDEWalgreen Companybcb81dc1-d854-30c0-e053-2a95a90a9fc72023-12-14WarningsExact identifier
application number: M012
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
application number: M012
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Sinus Severe, Circle KACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store products, Inc.e78c456f-f62e-596d-e053-2995a90a23972023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Max ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79f1a92-d8ea-e3f9-e053-2a95a90a2d372023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsbcc1a001-4176-485d-aaf0-2037ca65c6b82023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline No DripOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)0c006b1c-8ab2-4b9c-8738-e7001c1bb47d2023-12-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNc4732df0-e760-4283-98f3-2d08c8cd6a9e5
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDc4732df0-e760-4283-98f3-2d08c8cd6a9e5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYc4732df0-e760-4283-98f3-2d08c8cd6a9e5
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYc4732df0-e760-4283-98f3-2d08c8cd6a9e5
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYc4732df0-e760-4283-98f3-2d08c8cd6a9e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-032-3441520003234237 mL in 1 BOTTLE (41520-032-34) 237 ml2017-09-180000-00-00NoNoCurrent
41520-032-4041520003240355 mL in 1 BOTTLE (41520-032-40) 355 ml2017-09-180000-00-00NoNoCurrent