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 |
|---|---|---|---|---|---|---|
| Tussin DM Sugar free | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AARNA USA, Inc. | 3a521b65-fb35-4cc3-b826-88513afda0f9 | 2025-05-16 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 51c7628a-c7cf-498f-8fb1-db732e2b8b6e | 2025-05-16 | Warnings | M012 |
| BACTIMICINA CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | DLC Laboratories, Inc. | eaf554d4-a758-4ed6-bec5-d6cbfedae408 | 2025-05-15 | Warnings | M012 |
| Bactimicina Childrens Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | DLC Laboratories, Inc. | d407a583-07ae-4d47-b15a-24b5865c82da | 2025-05-15 | Warnings | M012 |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | RB Health (US) LLC | 35322238-d498-1a52-e063-6394a90ac9c4 | 2025-05-15 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | a1405038-80f2-45e5-bd8c-8c6b0ee348be | 2025-05-15 | Warnings | M012 |
| Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | b919f0fe-fae0-4bd8-9ccd-d7569b2a7070 | 2025-05-13 | Warnings | M012 |
| Childrens Robitussin Honey Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 6afaf85b-bf0c-4c99-acf3-a34f06be20f1 | 2025-05-13 | Warnings | M012 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 77be57fb-0ae5-4fad-97f3-b6a4b57383a9 | 2025-05-13 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | c948e612-a491-4ad0-adb9-cf31ef76e4d8 | 2025-05-12 | Warnings | M012 |
| Maximum Strength Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 2025-05-10 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Safeway, Inc. | c639a36d-c683-4a4d-90b7-eadec7464aa2 | 2025-05-08 | Warnings | M012 |
| Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645 | 2025-05-07 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 2b962d87-6ff5-4c0f-8504-e5b61c940612 | 2025-05-05 | Warnings | M012 |
| Cough and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID | CVS | 2d13564a-e8d1-c357-e063-6394a90ad90e | 2025-05-02 | Warnings | M012 |
| SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33fe0e49-3de5-8afd-e063-6294a90a0ad5 | 2025-05-02 | Warnings | M012 |
| Daytime and Nighttime High Blood Pressure Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy, Inc. | 2d13964a-8cc4-f3dc-e063-6394a90aa105 | 2025-05-02 | Warnings | M012 |
| DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | AARNA USA INC. | 32c26835-f54e-d7e5-e063-6294a90ae1c0 | 2025-04-30 | Warnings | M012 |
| SUDAFED OM Sinus Severe No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33e6239b-364a-0e62-e063-6294a90a5047 | 2025-04-29 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS Pharmacy | 8296049c-72fc-4200-9d45-c8e377314cf2 | 2025-04-29 | 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 |