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 |
|---|---|---|---|---|---|---|
| Mixed Berry Throat and Cough Lozenges | BENZOCAINE | CVS Pharmacy | 737b1c88-1a44-68cf-e053-2991aa0a35b6 | 2026-01-16 | Warnings | M012 |
| Walgreens Wild Cherry Throat Drops | PECTIN | Walgreens | 4885eca3-c1e9-8350-e063-6394a90ac290 | 2026-01-16 | Warnings | M012 |
| HBP Chest Congestion and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ff7a1462-9994-4421-85aa-c03488bb04cf | 2026-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | WALGREEN COMPANY | a793acbc-107c-4638-a2d7-65f4e96cafda | 2026-01-16 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ca53ec26-d167-1780-e053-2a95a90a5b88 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Congestion and Headache | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 88da92d2-92c2-445a-9b70-58996e086014 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 5f638bca-55c2-4ead-8c47-3f15713495da | 2026-01-16 | Warnings | M012 |
| COLD, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 190175bb-c08a-4050-aacf-29a130cbe05c | 2026-01-16 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | FSA Store Inc. (Caring Mills) | a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff | 2026-01-16 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 99147338-f459-4423-ae54-f96fffc1728d | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | 3429aedc-e83d-498a-bfca-03aaf5847b3b | 2026-01-15 | Warnings | M012 |
| Quality Choice Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 4b86101c-00f8-4ede-807f-db4273b37b8d | 2026-01-15 | Warnings | M012 |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | d1ba7267-6844-4a14-b518-65277a32e855 | 2026-01-15 | Warnings | M012 |
| ACTINEL DM Pediatric | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 2026-01-15 | Warnings | M012 |
| ACTINEL Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | ACTIPHARMA, LLC | 35c21623-84dd-4151-b35b-e7d30b69c9c0 | 2026-01-15 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | 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 |