VICKS FORMULA 44DM
- Product NDC
- 69423-811
- 11-digit product format
- 694230811
- Labeler code
- 69423
- Product ID
- 69423-811_5bc45a09-64f0-e07f-e063-6294a90a0780
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-25
- Marketing end
- 2026-12-30
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 650; 4; 30 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VICKS FORMULA 44DM
- Brand name suffix
- NIGHTTIME COUGH and COLD
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/15mL |
| CHLORPHENIRAMINE MALEATE | 4 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/15mL |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69423-811-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d35-111a-e063-dadaa90a10e2 | VICKS ® FORMULA 44™DM NIGHTTIME COUGH & COLD |
| 69423-811-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d35-111a-e063-dadaa90a10e2 | VICKS ® FORMULA 44™DM NIGHTTIME COUGH & COLD |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69423-811-12 | VICKS FORMULA 44DMNIGHTTIME COUGH and COLD | 354 mL in 1 BOTTLE, PLASTIC | LIQUID | 354 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69423-811 | VICKS FORMULA 44DM NIGHTTIME COUGH AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) LIQUID [PROCTER & GAMBLE MANUFACTURING COMPANY] | 4 | Current NDC, 1 package rows | 20241012_05414779-f61d-8fa7-e063-6394a90aa034.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 |
|---|---|---|---|---|---|---|
| Rompe Pecho CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 401a97af-36ae-4e54-e063-6294a90ab3ee | 2025-10-01 | Warnings | M012 |
| NyQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | 724d0889-5ba5-3125-e053-2a91aa0a92c1 | 2025-10-01 | Warnings | M012 |
| DayQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 724f2833-34bd-6a9e-e053-2991aa0a073d | 2025-10-01 | Warnings | M012 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | InvaTech Pharma Solutions LLC | b8d360fa-0d80-f6a8-e053-2a95a90a8bd4 | 2025-10-01 | M012 | |
| LEADER TUSSIN CF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | f4ffe87b-0a62-44ac-b84a-08cf77cda7f5 | 2025-10-01 | Warnings | M012 |
| Nasal Spray, 1oz, 24/7 Life by 7-Eleven | OXYMETAZOLINE HCL NASAL SOLUTION 0.05% | Lil' Drug Store Products, Inc. | 3e781417-9ffc-f2c9-e063-6294a90a7205 | 2025-09-30 | Warnings | M012 |
| Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf | 2025-09-30 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3ff240ba-90b2-4c17-e063-6394a90ac56f | 2025-09-29 | Warnings | M012 |
| Dometuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 3fcace53-a81f-e774-e063-6294a90a32fa | 2025-09-27 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f6a3680a-3ac6-4fd4-be52-ce29064c4aa1 | 2025-09-26 | Warnings | M012 |
| No Drip Severe Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | 9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5 | 2025-09-26 | Warnings | M012 |
| Giltuss Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa0b3be-2124-ed1d-e063-6294a90aaf48 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3fa17255-514f-db47-e063-6294a90ae454 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa17272-fd7f-9ab4-e063-6394a90a585f | 2025-09-25 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa2e438-2ff3-a2df-e063-6394a90ac7b5 | 2025-09-25 | Warnings | M012 |
| QUALITY CHOICE ADULT TUSSIN EXPECTORANT | GUAIFENESIN | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 63dad603-fe2f-42a6-a626-5c8048a42c10 | 2025-09-25 | Warnings | M012 |
| Giltuss Childrens Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa5220f-38bb-9ef6-e063-6294a90aeff8 | 2025-09-25 | Warnings | M012 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Health Pharma USA LLC | a03befb4-d86d-43e4-8097-eda5c8bb25be | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f8d7d47-f14c-888c-e063-6394a90a5cdd | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3f909bc2-eb84-a19d-e063-6294a90ae04e | 2025-09-24 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1292342 | acetaminophen 650 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 15 mL Oral Solution | PSN | 05414779-f61d-8fa7-e063-6394a90aa034 | 5 |
| 1292342 | acetaminophen 43.3 MG/ML / chlorpheniramine maleate 0.267 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral Solution | SCD | 05414779-f61d-8fa7-e063-6394a90aa034 | 5 |
| 1292342 | acetaminophen 650 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 15 ML Oral Solution | SY | 05414779-f61d-8fa7-e063-6394a90aa034 | 5 |
| 1292342 | APAP 43.3 MG/ML / chlorpheniramine maleate 0.267 MG/ML / dextromethorphan HBr 2 MG/ML Oral Solution | SY | 05414779-f61d-8fa7-e063-6394a90aa034 | 5 |
| 1292342 | APAP 43.3 MG/ML / Chlorpheniramine Maleate 0.267 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML Oral Solution | SY | 05414779-f61d-8fa7-e063-6394a90aa034 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-811-12 | 69423081112 | 354 mL in 1 BOTTLE, PLASTIC (69423-811-12) | 354 ml | 2021-01-25 | 2026-12-30 | No | No | Historical |