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 | 2026-10-15 | ||
| excluded package | package | 69423-964 | 69423-964-08 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Kids Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 | 2026-05-08 | Warnings | M012 |
| day time non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | f4fd597f-bca2-4ed4-b353-6c734f2f885c | 2026-05-08 | Warnings | M012 |
| Daytime Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | d8339bb0-5da3-4f34-a819-339643cf4a97 | 2026-05-08 | Warnings | M012 |
| severe tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | a26afc33-533e-4dc0-ab25-21be87356e22 | 2026-05-08 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | cdd53eba-1fa2-49c1-b03d-c32f309da7fb | 2026-05-08 | Warnings | M012 |
| Benadryl Allergy Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | bfeae100-e2d1-4607-be3b-2d9b15cd4f7f | 2026-05-07 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | H E B | 6503761f-37ae-4f39-b727-cb75d4c4a3c9 | 2026-05-07 | Warnings, Adverse reactions | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | ad199488-a4be-4b6e-b806-67ce8a6e907e | 2026-05-07 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HCL | L. Perrigo Company | 5d42adb9-3625-4072-a6b1-29a229f255c8 | 2026-05-07 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 4856cd7b-ccdf-4546-9c65-236ebaac3dca | 2026-05-06 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac | 2026-05-06 | Warnings | M012 |
| daytime cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 175cc2d0-0202-4e38-8af2-9fc126b7412d | 2026-05-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 90fae0fa-da07-4ea8-bdbd-39c2ed99ae59 | 2026-05-06 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 5d8b980f-0011-41e3-a881-ad10fe399079 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 38d12374-e2c7-444c-e063-6294a90a42b3 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 1ab295ff-94b1-c938-e063-6294a90a98fd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | M012 |
| Thieves Chest Rub | CHEST RUB | Young Living Essential Oils, LC. | 9b7f125e-6caa-c53e-e053-2a95a90a737e | 2026-05-06 | Warnings | M012 |
| Maximum Strength Mucus Relief Plus Pain and Headache | ACETAMINOPHEN, GUAIFENESIN | Shield Pharmaceuticals Corp | f20c0db1-dcf3-4bfc-b3e4-930398f82dc9 | 2026-05-06 | Warnings | M012 |
| Nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 8aa6492b-1723-4c6b-82ee-4f800301c6ad | 2026-05-06 | 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 |