Vicks NyQuil
- Product NDC
- 69423-995
- 11-digit product format
- 694230995
- Labeler code
- 69423
- Product ID
- 69423-995_5d1b1356-ec59-a707-e063-6394a90a3604
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
- Active strength
- 15; 6.25; 325 mg/1; mg/1; mg/1
- 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
- COLD and FLU
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
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 |
|---|---|---|---|---|---|---|
| 69423-995-02 | Vicks NyQuilCOLD and FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 12 | |
| 69423-995-08 | Vicks NyQuilCOLD and FLU | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 12 | |
| 69423-995-08 | Vicks NyQuilCOLD and FLU | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 12 | |
| 69423-995-16 | Vicks NyQuilCOLD and FLU | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 8 | 12 | |
| 69423-995-16 | Vicks NyQuilCOLD and FLU | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 12 | |
| 69423-995-24 | Vicks NyQuilCOLD and FLU | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 8 | 12 | |
| 69423-995-24 | Vicks NyQuilCOLD and FLU | 3 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 3 | 12 | |
| 69423-995-48 | Vicks NyQuilCOLD and FLU | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 12 | |
| 69423-995-48 | Vicks NyQuilCOLD and FLU | 24 in 1 CARTON | CAPSULE, LIQUID FILLED | 24 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69423-995 | VICKS NYQUIL COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 9 | Current NDC, Legacy NDC, 9 package rows | 20241012_efe4e649-7514-32dd-e053-2995a90a0492.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 |
|---|---|---|---|---|---|---|
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | M012 |
| care one nasal original | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | a0c35e06-c9e9-438e-8224-d4760b6e2aff | 2024-11-09 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Chewables | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | b08f71d8-a06c-41ba-8ed1-fbc41dbc1919 | 2024-11-08 | Warnings | M012 |
| SUDAFED PE SINUS CONGESTION | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 2024-11-08 | Warnings | M012 |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 2884d2dc-2d4a-4ca6-ab73-688a80b428eb | 2024-11-08 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 2024-11-08 | Warnings | M012 |
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | M012 |
| Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 685b51d3-cc25-47b2-ac8a-368924f43137 | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 60183922-bfd3-4377-884a-51b2f0a4c93a | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Congestion | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ca08917-1a75-4365-8520-c083e6a4225a | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 657a1e59-104c-4152-b2c9-00a8b82dc78e | 2024-11-08 | Warnings | M012 |
| Tylenol Cold plus Flu Severe and Tylenol Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 47c61858-72ce-409b-a3af-a63620cf7d13 | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | b8b75904-3806-4258-89c1-d6ff486ed41c | 2024-11-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 464de5de-0e7a-41d6-875f-dd0e5fe7893c | 2024-11-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | efe4e649-7514-32dd-e053-2995a90a0492 | 12 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | efe4e649-7514-32dd-e053-2995a90a0492 | 12 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | efe4e649-7514-32dd-e053-2995a90a0492 | 12 |
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | efb92829-1007-1c5d-e053-2a95a90a3c9b | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-995-02 | 69423099502 | 2 CAPSULE, LIQUID FILLED in 1 POUCH (69423-995-02) | 2021-01-01 | 0000-00-00 | No | No | Current | |
| 69423-995-08 | 69423099508 | 4 BLISTER PACK in 1 CARTON (69423-995-08) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2021-01-01 | 0000-00-00 | No | No | Current |
| 69423-995-16 | 69423099516 | 8 BLISTER PACK in 1 CARTON (69423-995-16) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 8 blister pack | 2021-01-01 | 0000-00-00 | No | No | Current |
| 69423-995-24 | 69423099524 | 8 BLISTER PACK in 1 CARTON (69423-995-24) / 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 8 blister pack | 2021-01-01 | No | No | Current | |
| 69423-995-48 | 69423099548 | 24 BLISTER PACK in 1 CARTON (69423-995-48) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 24 blister pack | 2021-01-01 | 0000-00-00 | No | No | Current |