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 |
|---|---|---|---|---|---|---|
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CHAIN DRUG MARKETING ASSOCIATION INC | 7d1b3418-85a8-4ca0-bca7-261b2b58032a | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH COLD, FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc. | bfc38500-5706-0d03-e053-2995a90a5c72 | 2026-03-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 2baa0861-dbef-7910-e063-6394a90a117e | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17d5ba7-3302-7931-e053-2a95a90a5a6c | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17b8f17-95f6-37e4-e053-2995a90a411a | 2026-03-26 | Warnings | M012 |
| Ultra concentrated Daytime/ Nighttime Severe Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL | CVS PHARMACY, INC | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23079537-1c06-1373-e063-6394a90a37d2 | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS MENTHOL SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2fa8c-071f-50ab-e063-6394a90a4a4a | 2026-03-26 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 2026-03-26 | Warnings | M012 |
| Vicks childrens Cough Congestion Night | PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 87231460-8b45-b995-e053-2a91aa0a6c43 | 2026-03-26 | Warnings | M012 |
| VICKS CHILDRENS COUGH CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | f1d67797-c806-261d-e053-2a95a90a3c15 | 2026-03-26 | Warnings | M012 |
| childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | 686f43ea-4296-4eee-b762-9a9e68344340 | 2026-03-26 | Warnings | M012 |
| Tussin DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59d3a486-97c2-4e60-90e2-1b5bfa7638c7 | 2026-03-26 | Warnings | M012 |
| flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Meijer Distribution Inc | 1a853e47-21a2-40e1-9e64-290af4843b13 | 2026-03-25 | Warnings | M012 |
| cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | c4dcc427-aeec-4a26-80f3-02a4b227a520 | 2026-03-25 | Warnings | M012 |
| Walgreens Lavender Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a1a00-852d-2756-e063-6394a90a5e29 | 2026-03-25 | Warnings | M012 |
| Walgreens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 2d56ddcd-3cc8-51eb-e063-6394a90ae745 | 2026-03-25 | 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 |