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 |
|---|---|---|---|---|---|---|
| Viro-Flu AM | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC | 551c957a-2e44-2b17-e063-6394a90a5295 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93fe6d-ee21-e323-e063-6394a90a61bf | 2026-07-15 | Warnings | M012 |
| Pentrexcilina Daytime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b7b3c15a-bb28-5c25-e053-2a95a90ad3b1 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93c815-63c7-bfe0-e063-6394a90ab4a5 | 2026-07-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALMART INC. (see also Equate) | 28251229-ad84-4573-aff0-fb0bed6cdfa1 | 2026-07-15 | Warnings | M012 |
| Viro Flu PM Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | 5693f346-8214-0112-e063-6394a90aabfb | 2026-07-14 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 5fa848ef-35ee-4e05-8ff2-781d034cf6ac | 2026-07-14 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | 0fad61d8-4393-47ec-9ff6-7df5be761f5b | 2026-07-14 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Rite Aid Corporation | 211c4273-3b2c-4169-b9c6-7a87903e77cd | 2026-07-13 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | f1a4ee57-33a3-4791-a769-b208b38acb72 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY Childrens Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | c499574c-f32b-4608-bf8b-51ad44e35725 | 2026-07-13 | Warnings | M012 |
| Good NeighborChildrens Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | f442c61b-7d2c-401c-b862-acbe2282927b | 2026-07-13 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 5683b099-f029-2d08-e063-6394a90ad482 | 2026-07-13 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f673cdeb-4f8b-46b4-be92-c725d74abc55 | 2026-07-13 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | e4fca5ba-2d45-4c38-b0fd-297159d1705a | 2026-07-13 | Warnings | M012 |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | AMERISOURCE BERGEN | 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 | 2026-07-13 | Warnings | M012 |
| Propolis Cooling Relief Cherry Cough Drops | MENTHOL, UNSPECIFIED FORM | Beekeeper's Naturals USA Inc | 7087566d-f24a-4508-aa25-7f42d055c43e | 2026-07-13 | Warnings | M012 |
| Sinus Pressure and Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Rite Aid Corporation | 35bcf263-3296-4d9c-84c0-146a173d6e87 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Childrens Cough Relief Cherry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | a8e2fd43-b801-41ae-8d79-8ecf4a771543 | 2026-07-13 | Warnings | M012 |
| Good Neighbor No Drip Nasal Mist Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | 7872aadd-b23c-431f-8048-24eece25ca2d | 2026-07-13 | 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 |