Vicks Formula 44
- Product NDC
- 69423-964
- 11-digit product format
- 694230964
- Labeler code
- 69423
- Product ID
- 69423-964_eb5399d1-373a-7876-e053-2995a90a2104
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 69423-964 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 69423-964 | 69423-964-08 | D | Discontinued by firm | 2026-10-16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69423-964-08 | Vicks Formula 44VapoCool Cough and Chest Congestion | 236 mL in 1 BOTTLE, PLASTIC | SOLUTION | 236 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69423-964 | VICKS FORMULA 44 VAPOCOOL COUGH AND CHEST CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 10 | Legacy NDC, 1 package rows | 20241012_d3bfce81-9e6d-6741-e053-2a95a90af183.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 |
|---|---|---|---|---|---|---|
| Aprodine | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Major Pharmaceuticals | 6612e514-2690-4f5b-8a82-0e54d362758f | 2025-11-19 | Warnings | M012 |
| Cough Drops Gems Flawless Cherry Flavor 30ct | MENTHOL | Riclan S.A. | 0f0260df-89ac-4b83-afea-3aff56ff1b43 | 2025-11-18 | Warnings | M012 |
| Cough Drops Gems Flawless Honey Lemon Flavor 30ct | MENTHOL | Riclan S.A. | 16f6d531-9298-4172-8d08-ecd87d6add76 | 2025-11-18 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | M012 |
| YINCHIAO | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 09ba45f6-03e1-46b9-83ab-a618b2626716 | 2025-11-18 | Warnings | M012 |
| GANMAOLING | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | c757a03e-59ea-469c-970d-4bc62e73f36f | 2025-11-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | e1d545dc-9222-4d61-964d-1c781215d7d2 | 2025-11-18 | Warnings | M012 |
| Goodnow cold flu day relief cold flu night relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Gobrands, Inc | 7590d0c6-121e-4016-b6bb-534c5d0a7970 | 2025-11-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | R J General Corporation | d786ae07-ce57-44c7-9ba5-f4c87df115de | 2025-11-17 | Warnings | M012 |
| Benadryl Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | R J General Corporation | c46c01c0-29f4-400c-bef5-14b3eb944c51 | 2025-11-17 | Warnings | M012 |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | M012 |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | R J General Corporation | 8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc | 2025-11-17 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | QUALITY CHOICE (Chain Drug Marketing Association) | c0e3c959-bed6-2ce5-e053-2995a90a0be9 | 2025-11-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | c5ea5a7a-c806-e5e0-e053-2995a90a15e9 | 2025-11-17 | Warnings | M012 |
| Multi-Symptom Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 50f3157b-5788-4b63-835a-e60c8dc33df9 | 2025-11-17 | Warnings | M012 |
| Day and Night Sinus | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | a9d809f5-63a1-4f80-8b4d-33e8e052c7bd | 2025-11-15 | Warnings | M012 |
| Cold and Flu Day, Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 937b481a-e0b7-4d34-a8a1-0bfb2b867c2b | 2025-11-15 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | f701a6ae-200d-48dc-94e4-6bd3228f50d4 | 2025-11-15 | Warnings | M012 |
| MULTI-SYMPTOM COLD | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b1fae7cc-4033-44bc-aa7c-ca3ceea51c7d | 2025-11-15 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | d3bfce81-9e6d-6741-e053-2a95a90af183 | 11 |
| 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 | d3bfce81-9e6d-6741-e053-2a95a90af183 | 11 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d3bfce81-9e6d-6741-e053-2a95a90af183 | 11 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d3bfce81-9e6d-6741-e053-2a95a90af183 | 11 |
| 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 | d3bfce81-9e6d-6741-e053-2a95a90af183 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-964-08 | 69423096408 | 236 mL in 1 BOTTLE, PLASTIC (69423-964-08) | 236 ml | 2018-07-10 | 0000-00-00 | No | No | Current |