Vicks NyQuil
- Product NDC
- 84126-357
- Requested package NDC
- 84126-357-08
- 11-digit product format
- 841260357
- Labeler code
- 84126
- Product ID
- 84126-357_5d1aef37-73c8-3753-e063-6294a90a0bed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- 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]
- 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
- Vicks NyQuil
- Brand name suffix
- INTENSE FLU
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 1000 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84126-357-08 | Vicks NyQuilINTENSE FLU | 236 mL in 1 BOTTLE, PLASTIC | LIQUID | 236 | 2 | |
| 84126-357-12 | Vicks NyQuilINTENSE FLU | 354 mL in 1 BOTTLE, PLASTIC | LIQUID | 354 | 2 | |
| 84126-357-12 | Vicks DayQuil and Vicks NyQuilINTENSE FLU | 354 mL in 1 BOTTLE, PLASTIC | LIQUID | 354 mL | 12.5 mg in 30mL | 1 |
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 |
|---|---|---|---|---|---|---|
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 721bfee2-0d3d-4d8b-beee-1ea83064d1c8 | 2024-01-23 | Warnings | M012 |
| Sugar Free Cough Drops Honey Lemon | MENTHOL | Cardinal Health 110, Inc. | fe90dc33-2815-8296-e053-6294a90ac1df | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Cardinal Health 110, Inc. | fe91543e-a798-6399-e053-6394a90af5e5 | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops Black Cherry | MENTHOL | Cardinal Health 110, Inc. | fe90cf63-d286-fa5e-e053-6394a90a7759 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol Honey Lemon | COUGH DROPS MENTHOL | Cardinal Health 110, Inc. | fe5b3f6d-2a2d-f322-e053-6394a90aba04 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol | MENTHOL COUGH DROPS | Cardinal Health 110, Inc. | fe5b557e-a689-a32c-e053-6294a90aadbd | 2024-01-19 | Warnings | M012 |
| Cough Drops Cherry | CHERRY FLAVOR COUGH DROPS | Cardinal Health 110, Inc. | fe5b5e57-1368-c62b-e053-6294a90ae82c | 2024-01-19 | Warnings | M012 |
| Leader Zinc Oxide | ZINC OXIDE | Cardinal Health 110,Inc. | 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 | 2024-01-18 | Warnings | M012 |
| Cough and Congestion DM Sugar Free | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 4656e60e-4733-45c1-bf55-d156e45085c6 | 2024-01-17 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Rugby Laboratories | 775f97c0-6f82-49a8-82ac-f1a73920c3ec | 2024-01-11 | Warnings | M012 |
| SinuFrin NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae | 2024-01-11 | Warnings | M012 |
| SinuFrin Plus NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals, Inc. | 99afe6a6-1350-49c6-9347-b7e531e35925 | 2024-01-11 | Warnings | M012 |
| Childrens Tukol Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 85fe6f0f-41c8-44d3-a34a-355938da5f72 | 2024-01-11 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | ad437177-08eb-4811-883f-ac543d5bc58c | 2024-01-11 | Warnings | M012 |
| Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | af5053d8-ba02-4cdf-877f-8c1e368dafe0 | 2024-01-10 | Warnings | M012 |
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | M012 |
| HISTEX-DM | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 836d062c-29f0-4fd7-b65c-771a3bbd52c4 | 2024-01-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1042684 | acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | 326e3a20-7bcb-0e24-e063-6394a90af327 | 2 |
| 1042684 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 326e3a20-7bcb-0e24-e063-6394a90af327 | 2 |
| 1042684 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 326e3a20-7bcb-0e24-e063-6394a90af327 | 2 |
| 1042684 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 326e3a20-7bcb-0e24-e063-6394a90af327 | 2 |
| 1042684 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 326e3a20-7bcb-0e24-e063-6394a90af327 | 2 |
| 1242575 | {1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } Pack | GPCK | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1242575 | 1 nighttime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) / 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG in 15 mL Oral Solution) Pack | PSN | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1042684 | acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1359455 | acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution | PSN | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1042684 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1359455 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1242575 | 1 nighttime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution) / 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution) Pack | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1042684 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1359455 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1042684 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1359455 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1042684 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
| 1359455 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 32bea3dc-9889-22dd-e063-6394a90afa1b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84126-357-08 | 84126035708 | 236 mL in 1 BOTTLE, PLASTIC (84126-357-08) | 236 ml | 2025-07-07 | No | No | Current |