NyQuil VapoCOOL SEVERE
- Product NDC
- 69423-989
- 11-digit product format
- 694230989
- Labeler code
- 69423
- Product ID
- 69423-989_5ce1634c-0609-ece7-e063-6394a90a386e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-22
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
- Active strength
- 10; 12.5; 20; 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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
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
- NyQuil VapoCOOL SEVERE
- Brand name suffix
- COLD and FLU plus CONGESTION
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| ACETAMINOPHEN | 650 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69423-989-08 | NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION | 236 mL in 1 BOTTLE, PLASTIC | SOLUTION | 236 | 8 | |
| 69423-989-12 | NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION | 354 mL in 1 BOTTLE, PLASTIC | SOLUTION | 354 | 8 | |
| 69423-989-08 | DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION | 236 mL in 1 BOTTLE, PLASTIC | SOLUTION | 236 mL | 650 mg in 30mL | 7 |
| 69423-989-12 | DayQuil and NyQuil VapoCOOL SEVERECOLD and FLU plus CONGESTION | 354 mL in 1 BOTTLE, PLASTIC | SOLUTION | 236 mL | 650 mg in 30mL | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69423-989 | DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 6 | Current NDC, Legacy NDC | 20241114_fbd53e5f-bc03-75b4-e053-6394a90af028.zip |
| 69423-989 | NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241012_ef6df67c-0afa-4825-e053-2995a90aced9.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | ef6df67c-0afa-4825-e053-2995a90aced9 | 8 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | ef6df67c-0afa-4825-e053-2995a90aced9 | 8 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | ef6df67c-0afa-4825-e053-2995a90aced9 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | ef6df67c-0afa-4825-e053-2995a90aced9 | 8 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | ef6df67c-0afa-4825-e053-2995a90aced9 | 8 |
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | fbd53e5f-bc03-75b4-e053-6394a90af028 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-989-08 | 69423098908 | 236 mL in 1 BOTTLE, PLASTIC (69423-989-08) | 236 ml | 2021-03-22 | 0000-00-00 | No | No | Current |
| 69423-989-12 | 69423098912 | 354 mL in 1 BOTTLE, PLASTIC (69423-989-12) | 354 ml | 2021-03-22 | 0000-00-00 | No | No | Current |