NyQuil VapoCOOL SEVERE
- Product NDC
- 69423-989
- 11-digit product format
- 694230989
- Labeler code
- 69423
- Product ID
- 69423-989_502449a6-410b-7952-e063-6294a90a82cd
- 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
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 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
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 |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ |
| Rxcui | 1431245 |
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69423-989-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-17ea-111a-e063-dadaa90a10e2 | Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid |
| 69423-989-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-17ea-111a-e063-dadaa90a10e2 | Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION Liquid |
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 |
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 |