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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 41520-032 | 41520-032-34 | D | Discontinued by firm | 2026-10-05 |
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.
| 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
- CareOne DayTime Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41520-032-34 | CareOne DayTime Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 5 | |
| 41520-032-40 | CareOne DayTime Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41520-032 | CAREONE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [AMERICAN SALES COMPANY] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240927_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 66543190-1d3d-4259-ae73-d366ecbf9e52 | 2026-05-12 | Warnings | M012 |
| basic care daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 612719a9-fa2e-4c40-8f35-a399aeaafecc | 2026-05-12 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 3cac44ad-1835-487e-b6d0-1483d724bb5e | 2026-05-12 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | 9cfb1abb-98c4-4e90-8dd7-fcffc112f988 | 2026-05-12 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab51b36-1c2e-4c97-932c-dacfaf55935a | 2026-05-11 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa | 2026-05-11 | Warnings | M012 |
| NebuClear MD | SALINE | Blue Echo Care LLC | 3f85fe62-230f-b0f1-e063-6394a90a5cb8 | 2026-05-11 | Warnings | M012 |
| Device - NebuClear MD Hand-held Rubber Bulb Nebulizer | DEVICE - HAND-HELD RUBBER BULB NEBULIZER | Blue Echo Care LLC | 43e0a646-be57-1024-e063-6394a90a43e4 | 2026-05-11 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1efd1778-7ab1-4797-98c5-4637940ee3ec | 2026-05-11 | Warnings | M012 |
| DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR | AptaPharma Inc. | 0380035e-44d5-44ea-9d1c-d57a1de65188 | 2026-05-10 | Warnings | M012 |
| Night Time Cold and Flu relief liquid filled softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE | AptaPharma Inc. | d61e2186-8b59-45f9-96ec-83430a0fe0cb | 2026-05-10 | Warnings | M012 |
| Maximum Strength Tussin DM Liquid filled Softgels | DEXTROMETHORPHAN HBR, GUAIFENESIN | AptaPharma Inc. | 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 | 2026-05-10 | Warnings | M012 |
| Day-Time Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c | 2026-05-10 | Warnings | M012 |
| Daytime Cold and Flu Relief Liquid Filled Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c078efb5-d30e-4dd1-a600-6e827390df76 | 2026-05-10 | Warnings | M012 |
| DM Max CONGESTION and COUGH | DEXTROMETHORPHAN HBR, GUAIFENESIN | DeMoulas Market Basket | b12e26b2-79e4-45a5-9a90-4630f92457d0 | 2026-05-09 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | fac55d76-457f-4258-9cc8-6edae539cada | 2026-05-08 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | HyVee Inc | 5a0ef8ae-f6d5-4388-b4da-6b7f025160b2 | 2026-05-08 | Warnings | M012 |
| Halls Variety Pack Mentholyptus Honey Lemon Cherry | MENTHOL | Mondelez Global LLC | 512a9a2e-6160-80d1-e063-6394a90aeff0 | 2026-05-08 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5150ff85-85bb-9cd9-e063-6294a90a1144 | 2026-05-08 | Warnings | M012 |
| Dr. Simi Children s Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Farmacias De Similares TX LLC | 5151740a-8270-7bb5-e063-6294a90ae387 | 2026-05-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | c4732df0-e760-4283-98f3-2d08c8cd6a9e | 5 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | c4732df0-e760-4283-98f3-2d08c8cd6a9e | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | c4732df0-e760-4283-98f3-2d08c8cd6a9e | 5 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | c4732df0-e760-4283-98f3-2d08c8cd6a9e | 5 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | c4732df0-e760-4283-98f3-2d08c8cd6a9e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41520-032-34 | 41520003234 | 237 mL in 1 BOTTLE (41520-032-34) | 237 ml | 2017-09-18 | 0000-00-00 | No | No | Current |
| 41520-032-40 | 41520003240 | 355 mL in 1 BOTTLE (41520-032-40) | 355 ml | 2017-09-18 | 0000-00-00 | No | No | Current |