daytime nighttime cold and flu
- Product NDC
- 0363-0567
- 11-digit product format
- 003630567
- Labeler code
- 0363
- Product ID
- 0363-0567_cdeae508-e83b-41a9-a7a1-41269b64ac99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-09-06
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0363-0567-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0363-0567-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0363-0567-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0363-0567-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0363-0567-02 | cdf11ea48f46… | ba0047e9e063… |
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 nighttime cold and flu
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0401-40 | daytime nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 11 |
| 0363-0567-02 | daytime nighttime cold and flu | 1 in 1 CARTON | KIT | 1 | 11 | |
| 0363-0666-40 | daytime nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 5 mg in 15mL | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0567-02 | ML - Milliliter | 0363-0567 | 0b3b35ee-f5b9-4497-899e-6912d7b89b12 | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| 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 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b9215a5e-3be8-44fd-9189-50dab760869c | 2026-01-06 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Major Pharmaceuticals | f81efbf4-204b-45be-ae32-910d9e4ae4aa | 2026-01-06 | Warnings | M012 |
| SINUS AND NASAL DECONGESTANT | PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d7646859-f996-46cd-a0b9-56b860f60901 | 2026-01-05 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | HY-VEE, INC | 47a71cdf-856d-9ecd-e063-6294a90a70c6 | 2026-01-05 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Oncor Pharmaceuticals | fd35036c-b722-48a3-85fd-60471beb6e74 | 2026-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals,Inc. | 3c323dc8-f734-b44c-e063-6394a90a6184 | 2026-01-05 | Warnings | M012 |
| Congestion and Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f43d97b1-aeb9-4ca5-8909-b28e7bf764f5 | 2026-01-05 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | 6bd2b8fd-2023-413b-8988-a47d2058dc85 | 2026-01-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WinCo Foods, LLC | 4c1046df-53a6-4219-83ac-bbf5cf4db9c8 | 2026-01-05 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 80323208-9ba5-432b-a8a0-0c0b51e67145 | 2026-01-05 | Warnings | M012 |
| Sinus Pressure and Pain PE Maximum Strength | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 347868e4-0182-4e16-895c-ec269895c57c | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Cherry | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | c5b11a9c-6d93-4772-93c2-1ef5c5647016 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fae96736-1453-42fe-8158-cde770b23165 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Menthol | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd | 2026-01-02 | Warnings | M012 |
| Reliable-1 Tussin | GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | 2a33ff82-49df-7aaa-e063-6294a90a1281 | 2026-01-02 | Warnings | M012 |
| Tussin DMMax | DEXTROMETHORPHAN HBR, GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa | 2026-01-02 | Warnings | M012 |
| Severe Sinus Pain and Congestion Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7 | 2026-01-02 | Warnings | M012 |
| NUVALU VAPORIZING CHEST RUB | CAMPHOR, EUCALYPTUS OIL, MENTHOL | JC SALES | 490b2d1e-3a1d-1a52-e063-6394a90a00ba | 2026-01-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0401-40 | 00363040140 | 355 mL in 1 BOTTLE | 355 ml | Historical | ||||
| 0363-0567-02 | 00363056702 | 1 KIT in 1 CARTON (0363-0567-02) * 355 mL in 1 BOTTLE (0363-0401-40) * 355 mL in 1 BOTTLE (0363-0666-40) | 1 kit | 2012-09-06 | 0000-00-00 | No | No | Current |
| 0363-0666-40 | 00363066640 | 355 mL in 1 BOTTLE | 355 ml | Historical |