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 | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | db264d2f-bf81-4da2-8595-2bfa1e4ba2f1 | 2026-05-18 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c | 2026-05-15 | Warnings | M012 |
| good neighbor pharmacy cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | da91e6b6-32ff-44fd-afce-33ea9549554b | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | 847cdee8-410f-4ff3-9245-976ed6f4c776 | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | d3b2f300-d919-44cd-ab71-b74b5bdfd977 | 2026-05-15 | Warnings | M012 |
| ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER | ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS | MEDWISE LIFESCIENCES INC. | 51d52ce4-98c4-2b9b-e063-6294a90ade44 | 2026-05-15 | Warnings | M012 |
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Honey Lemon | MENTHOL | Melaleuca, Inc. | 84ac3489-9d64-401f-ab78-715af4de5440 | 2026-05-15 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 51e03b5b-b05a-07c1-e063-6394a90ab201 | 2026-05-15 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytime | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 38d73a1e-ac78-4f67-9291-bb48ab80306e | 2026-05-15 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALMART INC. | 071615ba-f50a-4d2a-a358-43140bccce72 | 2026-05-14 | Warnings | M012 |
| Severe Cold and Flu Nighttime Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | d4bcfabb-a054-4f53-8dc9-d361a03558b8 | 2026-05-14 | Warnings | M012 |
| Cough and Chest Congestion DM Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 4444c05a-eba6-4633-b86f-34f455699fa9 | 2026-05-14 | Warnings | M012 |
| Topcare Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 2026-05-14 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 69b24c67-cf4b-46d7-a44b-d1917cc876b1 | 2026-05-14 | Warnings | M012 |
| GILTUSS DIABETIC EX | GILTUSS DIABETIC EX | Gil Pharmaceutical Corp | ab7915e7-323a-4fe1-887a-a3bd3f0aac98 | 2026-05-13 | Warnings | M012 |
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | M012 |
| Giltuss EX Expectorant | GILTUSS EX EXPECTORANT | Gil Pharmaceutical Corp | 3b363fb9-c4d3-446f-927c-f705ffc715b5 | 2026-05-13 | Warnings | M012 |
| Giltuss HBP EX Expectorant | GILTUSS HBP EX EXPECTORANT | Gil Pharmaceutical Corp | 31bd6356-27cf-4188-8fd5-9cd9392021ca | 2026-05-13 | 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 |