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 |
|---|---|---|---|---|---|---|
| Dologesic DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 55768b45-fd98-4779-85b6-6a50c628677e | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL | Llorens Pharmaceutical International Division, Inc. | e9a8deb4-0595-4f0f-ac15-f936f15aca88 | 2025-12-31 | Warnings | M012 |
| Tusnel | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 805dc611-355a-4af5-bf19-464c3290c5c6 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 82f447f6-4f1b-4f56-9d7d-ea02adeea88c | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | cc774d33-96ce-4992-ad30-3cb03b0d119d | 2025-12-31 | Warnings | M012 |
| Tusnel SF | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cb43b4df-5ccc-416e-abcd-98f079b3f2bb | 2025-12-31 | Warnings | M012 |
| Tusnel Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | af71cdbc-33d6-4303-b494-d7321721d3be | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | 63541753-de8d-42fe-a9b3-a5eac3fcdca4 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric Drops | GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 | 2025-12-31 | Warnings | M012 |
| Tusnel DM Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | d915eab8-013e-4ce3-b358-0d531e5ca1ba | 2025-12-31 | Warnings | M012 |
| Tusnel-DM Pediatric | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 64e36b02-b5be-4d20-8818-cb5b23596671 | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f89a64-f4a4-f909-e053-2a91aa0ad44d | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f65f59-7ea1-adce-e053-2991aa0a6f1f | 2025-12-31 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f9e176-d87a-beed-e053-2991aa0aac20 | 2025-12-31 | Warnings | M012 |
| Sugar Free Cherry Cough Drops | MENTHOL | Bestco Inc. | 7858f380-bef7-3d30-e053-2a91aa0a7ea6 | 2025-12-31 | Warnings | M012 |
| Strawberry Cough Drops | MENTHOL | BestCo Inc. | 26a22cfd-395b-4ffb-e054-00144ff88e88 | 2025-12-31 | Warnings | M012 |
| Limpia Pecho | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3 | 2025-12-31 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE | Bestco Inc. | 737efd41-2d59-6013-e053-2a91aa0a6c63 | 2025-12-31 | Warnings | M012 |
| Best Health Menthol Cough Drops | MENTHOL | Bestco LLC | dda66a3c-9006-ff1a-e053-2a95a90abfb3 | 2025-12-31 | Warnings | M012 |
| Rynex DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Edwards Pharmaceuticals, Inc | 7be2c282-24ba-4f19-9b14-872d3f5746a7 | 2025-12-31 | 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 |