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 | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c1fae6c7-bbac-1320-e053-2a95a90aac5a | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Day Severe Cold Plus Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | cec51eab-cce3-4965-a14e-a46d953050c4 | 2026-01-08 | Warnings | M012 |
| VanaCof 2 | CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE | GM Pharmaceuticals, INC | 0c7c6756-abb2-c10c-e063-6394a90a9863 | 2026-01-08 | Warnings | M012 |
| VANACOF XP Cough / Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | GM Pharmaceuticals, INC | 0b3a8cc1-a49f-e1e5-e063-6394a90a1c06 | 2026-01-08 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | INVAHEALTH INC | e4e4004f-77e3-569d-e053-2a95a90a73fe | 2026-01-08 | Warnings | M012 |
| Robitussin Maximum Strength Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 868ac65a-63e2-46ac-b87d-66b289086756 | 2026-01-08 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 0324195f-506d-4747-990e-ad44e2a117d9 | 2026-01-07 | Warnings | M012 |
| Sambrosa Night | DOXYLAMINE SUCCINATE | Sambrosa Care, Inc. | acdc8740-6231-d1e8-e053-2995a90a3b8d | 2026-01-07 | Warnings | M012 |
| VAPOREX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | DLC Laboratories, Inc. | 971943b1-4199-4f75-9d2d-61242d346b5f | 2026-01-07 | Warnings | M012 |
| BACTIMICINA COUGH AND COLD | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DLC Laboratories, Inc. | 2e612c62-9bbb-45f2-a253-aa2bfaeaac70 | 2026-01-07 | Warnings | M012 |
| Earths Care Chest Rub | CAMPHOR, EUCALYPTUS OI, MENTHOL | DLC Laboratories, Inc | 2424f5d5-1772-96f1-e063-6294a90a89ee | 2026-01-07 | Warnings | M012 |
| Bactimicina Vapor Rub | VAPOR RUB | DLC Laboratories, Inc. | 176b617a-faf6-7893-e063-6294a90a046b | 2026-01-07 | Warnings | M012 |
| Sinus Pressure and Pain | ACETAMINOPHEN, PHENYLEPHRINE HCL | Family Dollar Services Inc | 0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2 | 2026-01-07 | Warnings | M012 |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | b225e897-5728-4519-b727-c0f361c75976 | 2026-01-07 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 80b218f7-66bb-4e15-a0dc-ec9b6af1b056 | 2026-01-07 | Warnings | M012 |
| tussin cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 13618054-d0c5-4190-b626-e7e91b855738 | 2026-01-06 | Warnings | M012 |
| Berkley and Jensen Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | c15b97a8-968f-4d38-905e-863e9fd16ce6 | 2026-01-06 | Warnings | M012 |
| Complete Allergy Medicine | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | c0f5c8ca-b187-40bf-9245-6a29f1c32c97 | 2026-01-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | c5776b1e-9f72-4a6a-9961-8ac8e05b3249 | 2026-01-06 | 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 |