Nighttime Cold and Flu
- Product NDC
- 0363-0460
- 11-digit product format
- 003630460
- Labeler code
- 0363
- Product ID
- 0363-0460_e52e087d-ec2a-49b7-8d47-955d8c0daa93
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Walgreens
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-30
- Marketing end
- 2026-12-28
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
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
- Nighttime Cold and Flu
- Brand name suffix
- Maximum Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1375932 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 37896933-3ed3-457f-8a32-ee0d784a19e8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0460-06 | Nighttime Cold and FluMaximum Strength | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 7 | |
| 0363-0460-06 | Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and FluMaximum Strength | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 mL | 650 mg in 20mL | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0460-06 | ML - Milliliter | 0363-0460 | 7b2a4e71-1b15-4bbc-8262-c63652fc805e | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0460 | DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI) KIT [WALGREENS] | 7 | Current NDC, Legacy NDC | 20240717_366ddac8-9e8a-41bd-a7f7-48213485a5f8.zip |
| 0363-0460 | NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) LIQUID [WALGREENS] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240718_37896933-3ed3-457f-8a32-ee0d784a19e8.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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | Warnings | M012 |
| Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 66543190-1d3d-4259-ae73-d366ecbf9e52 | 2026-05-12 | Warnings | M012 |
| basic care daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 612719a9-fa2e-4c40-8f35-a399aeaafecc | 2026-05-12 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 3cac44ad-1835-487e-b6d0-1483d724bb5e | 2026-05-12 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | 9cfb1abb-98c4-4e90-8dd7-fcffc112f988 | 2026-05-12 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab51b36-1c2e-4c97-932c-dacfaf55935a | 2026-05-11 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa | 2026-05-11 | Warnings | M012 |
| NebuClear MD | SALINE | Blue Echo Care LLC | 3f85fe62-230f-b0f1-e063-6394a90a5cb8 | 2026-05-11 | Warnings | M012 |
| Device - NebuClear MD Hand-held Rubber Bulb Nebulizer | DEVICE - HAND-HELD RUBBER BULB NEBULIZER | Blue Echo Care LLC | 43e0a646-be57-1024-e063-6394a90a43e4 | 2026-05-11 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1efd1778-7ab1-4797-98c5-4637940ee3ec | 2026-05-11 | Warnings | M012 |
| DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR | AptaPharma Inc. | 0380035e-44d5-44ea-9d1c-d57a1de65188 | 2026-05-10 | Warnings | M012 |
| Night Time Cold and Flu relief liquid filled softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE | AptaPharma Inc. | d61e2186-8b59-45f9-96ec-83430a0fe0cb | 2026-05-10 | Warnings | M012 |
| Maximum Strength Tussin DM Liquid filled Softgels | DEXTROMETHORPHAN HBR, GUAIFENESIN | AptaPharma Inc. | 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 | 2026-05-10 | Warnings | M012 |
| Day-Time Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c | 2026-05-10 | Warnings | M012 |
| Daytime Cold and Flu Relief Liquid Filled Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c078efb5-d30e-4dd1-a600-6e827390df76 | 2026-05-10 | Warnings | M012 |
| DM Max CONGESTION and COUGH | DEXTROMETHORPHAN HBR, GUAIFENESIN | DeMoulas Market Basket | b12e26b2-79e4-45a5-9a90-4630f92457d0 | 2026-05-09 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | fac55d76-457f-4258-9cc8-6edae539cada | 2026-05-08 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | HyVee Inc | 5a0ef8ae-f6d5-4388-b4da-6b7f025160b2 | 2026-05-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637728 | {1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) Pack | PSN | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 7 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0460-06 | 00363046006 | 177 mL in 1 BOTTLE, PLASTIC (0363-0460-06) | 177 ml | 2015-06-30 | 2026-12-28 | No | No | Current |