Daytime cold and flu
- Product NDC
- 41250-656
- 11-digit product format
- 412500656
- Labeler code
- 41250
- Product ID
- 41250-656_ca0850da-738b-488b-9782-80c8dec7e9bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Meijer Distribution Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-09-15
- 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 | 41250-656 | 41250-656-38 | D | Discontinued by firm | 2026-10-16 |
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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Daytime cold and flu
- Brand name suffix
- non drowsy
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-656-38 | Daytime cold and flunon drowsy | 296 mL in 1 BOTTLE | SOLUTION | 296 | 10 | |
| 41250-656-40 | Daytime cold and flunon drowsy | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 41250-656-40 | daytime nitetime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 325 mg in 15mL | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41250-656 | DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241016_29caa3a7-7fe6-4134-a9b0-49bdb9280ca7.zip |
| 41250-656 | DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER, INC.] | 7 | Current NDC, Legacy NDC | 20241205_80aae1c3-a616-442b-842e-177db957a69c.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 |
|---|---|---|---|---|---|---|
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | Warnings | M012 |
| equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 3862aaa5-2281-e8f9-e063-6294a90a0f7e | 2025-09-09 | Warnings | M012 |
| McKesson Sugar Free Cough Suppressant Oral Anesthetic | MENTHOL LOZENGE | McKesson Medical-Surgical | e0dfa6ca-b311-25cb-e053-2a95a90a12cc | 2025-09-09 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e648f017-9e30-df6c-e053-2995a90adcd0 | 2025-09-09 | Warnings | M012 |
| Medi-First Honey Lemon Cough Drops | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 826e1b87-e5a9-8637-e053-2991aa0aded1 | 2025-09-09 | Warnings | M012 |
| Unishield Cherry Cough | MENTHOL | Unishield | b8297bc1-44b2-3de0-e053-2995a90ad01b | 2025-09-09 | Warnings | M012 |
| McKesson Cough Supressant | MENTHOL | McKesson Medical-Surgical | db5e0490-2ed8-2d53-e053-2a95a90a98f5 | 2025-09-09 | Warnings | M012 |
| Duratuss AC | CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 3e5ed178-d5d9-b8d4-e063-6394a90a91db | 2025-09-09 | Warnings | M012 |
| Rompe Pecho CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Efficient Laboratories Inc | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 57c458ed-7987-453b-ab24-bbfa6580f920 | 2025-09-09 | Warnings | M012 |
| equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 38637189-d1ee-9405-e063-6394a90ae8b8 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | fd52d8d8-7cd1-4e92-86da-354a1d5213c2 | 2025-09-08 | Warnings | M012 |
| Green Guard Advanced Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e8e5fb21-a7fd-44d1-b9c4-83e949699ca6 | 2025-09-08 | 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 | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 10 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 10 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 10 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 10 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 10 |
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-656-38 | 41250065638 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 41250-656-40 | 41250065640 | 355 mL in 1 BOTTLE (41250-656-40) | 355 ml | 2008-08-30 | 0000-00-00 | No | No | Current |