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 |
|---|---|---|---|---|---|---|
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38049d29-f47e-9478-e063-6294a90aa2a4 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3804a271-9a11-848d-e063-6394a90af87d | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805ef07-247d-0df7-e063-6394a90ac45b | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805f8f5-562f-0ba8-e063-6394a90ac9d9 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Army & Air Force Exchange Service | 3805f90e-bd89-128d-e063-6394a90afa01 | 2025-06-20 | Warnings | M012 |
| TARGET Multi Symptom Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | aebe3c15-53ef-46ea-af39-8c9b8114595f | 2025-06-20 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | be95332d-a2e0-42e8-bfb3-8850d74990ff | 2025-06-19 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | 37e939c6-064b-3548-e063-6294a90a337d | 2025-06-19 | Warnings | M012 |
| Capron DM | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | cf778c5f-475e-4a86-a87c-2be1e665f5a5 | 2025-06-18 | Warnings | M012 |
| Cough Out | GUAIFENESIN | Efficient Laboratories Inc. | fe4c3921-8d30-4cd6-ba90-9211b362a38a | 2025-06-18 | Warnings | M012 |
| Guaifenesin STRAWBERRY-BANANA FLAVOR | GUAIFENESIN | Innovida Pharmaeutique Corporation | 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16 | 2025-06-18 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool | ACETAMINOPHEN AND GUAIFENESIN | RB Health (US) LLC | 37de813a-54b7-672a-e063-6294a90a374e | 2025-06-18 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a1aeb41-a8fa-4116-8068-e11acd608e58 | 2025-06-18 | Warnings | M012 |
| NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c768f5-dabd-22d0-e063-6394a90af9e5 | 2025-06-17 | Warnings | M012 |
| DISCOUNT DRUG MART Childrens Allergy Chewable | DIPHENHYDRAMINE HCL | DISCOUNT DRUG MART | 51de95da-e8e8-48f0-9fa4-6191aa4a247b | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | 5f4af8e8-8550-45c7-a199-694efac9e7be | 2025-06-16 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | 25eaae85-d516-40da-a472-70736ea2b75d | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | bad89968-22a7-4287-a57c-9e6206e574fe | 2025-06-16 | Warnings | M012 |
| Herbal Throat Drops | LEMON MINT HERBAL | Meijer, Inc. | 37dd58ad-95d1-568c-e063-6394a90a9433 | 2025-06-16 | Warnings | M012 |
| topcare childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | 40a6a7e3-6ec9-4005-9406-9d5b044b3c21 | 2025-06-16 | 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 |