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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | BETTER LIVING BRANDS, LLC | 46adbf94-5b93-ee64-e063-6294a90a1144 | 2026-04-11 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | 0c79357a-b79d-4952-8e6d-ef3d60dde2fa | 2026-04-10 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 88d27c25-a305-4398-9590-df10d2504b01 | 2026-04-09 | Warnings | M012 |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb | 2026-04-09 | Warnings | M012 |
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | e20b1093-d77f-4c39-b105-adaa1b82ea76 | 2026-04-09 | Warnings | M012 |
| Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 4f0c1b8e-3fb1-ccf2-e063-6394a90acd15 | 2026-04-09 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Lidl US LLC | b26ac105-f8e4-4ad0-8a26-9fdf30c01700 | 2026-04-09 | Warnings | M012 |
| Wal Dryl Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 09de28cd-fa60-4af7-b7cc-cf74c00a3531 | 2026-04-09 | Warnings | M012 |
| Tussin DM Max NIGHTTIME | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | d10a413e-22a6-4799-8367-5777831756a9 | 2026-04-09 | Warnings | M012 |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 80d25e23-b108-4eb1-88c7-73fe9da8f942 | 2026-04-09 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR AND GUAIFENESIN | L.N.K. International, Inc. | 2fea3533-8218-4875-affe-5b33a22c553a | 2026-04-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 2026-04-08 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | e24121d2-c9d2-4bbd-869e-eeed7e2bb881 | 2026-04-08 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 8460d4f9-8d7b-4ae4-8047-c2010d9c8013 | 2026-04-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | d2dab450-cf82-4be2-a4e2-630295fb59ab | 2026-04-08 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 4657c02b-887b-4746-8a78-83a72465e07b | 2026-04-08 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 33646fab-79a5-4f10-8ac0-48423eac9b56 | 2026-04-07 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 76e19b9a-3bdb-479a-9503-9e8250109c84 | 2026-04-07 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 7959ea00-2a41-4c3c-8c58-85795ebd2afc | 2026-04-06 | 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 |