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 |
|---|---|---|---|---|---|---|
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b | 2026-02-17 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | e8a48a00-3533-4c4d-94e1-8a6c6b35a792 | 2026-02-17 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | 1f3efcdd-4976-4aef-a7c6-a5f88d13cb78 | 2026-02-17 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 2026-02-17 | Warnings | M012 |
| Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Chain Drug Marketing Association, Inc. | 3c8f34ad-589a-4872-939c-44ad5e0e47fe | 2026-02-17 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Valu Merchandisers Company | b6144732-99da-4be2-88e0-75f31b323d38 | 2026-02-16 | Warnings, Adverse reactions | M012 |
| topcare day time cold and flu relief multi symptom relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates LLC | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 2026-02-16 | Warnings | M012 |
| Revasol Acetaminophen Suspension | ACETAMINOPHEN | Rnv LLC | 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 | 2026-02-13 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Topco Associates LLC | 62eed0e8-ba5f-45c2-a543-68b50bcf4b0c | 2026-02-13 | Warnings, Adverse reactions | M012 |
| Revasol Acetaminophen Suspension Dye Free | ACETAMINOPHEN | Rnv LLC | 4abc07b3-6a27-260f-e063-6394a90a28d6 | 2026-02-13 | Warnings | M012 |
| robafen dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Major Pharmaceuticals | 5e19220d-9cf3-4732-b9aa-c09db5d69ce6 | 2026-02-13 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 686b9456-f16d-4b99-ae58-f607448bed8b | 2026-02-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | 1c3dc4e6-452b-4c84-b53c-426cf9ae8f03 | 2026-02-12 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | af42d3f7-661e-4322-aefe-2b7f9f1010d6 | 2026-02-12 | Warnings | M012 |
| Childrens Giltuss D | CHILDRENS GILTUSS D | Gil Pharmaceutical Corp | cfc2493b-e99e-4b55-98a9-053f95d49844 | 2026-02-12 | Warnings | M012 |
| Giltuss D | GILTUSS D | Gil Pharmaceutical Corp | 298f5457-a7df-474d-9854-68918ee3d330 | 2026-02-12 | Warnings | M012 |
| Vaporizing | CAMPHOR | Walgreen Co. | ef4f95c8-7650-4096-9369-ea8393781bee | 2026-02-12 | Warnings, Adverse reactions | M012 |
| Oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | Prodose, Inc. | 3dce34f0-9f6d-8151-e063-6394a90a1d38 | 2026-02-11 | Warnings | M012 |
| SIGNATURE CARE Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | SAFEWAY | 831da7b6-25c7-4601-b7f1-1800a238b016 | 2026-02-11 | Warnings | M012 |
| Allergy Plus Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d2cf481-622f-4262-b0bd-c38fe5de6721 | 2026-02-11 | 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 |