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 | 2026-10-23 | ||
| excluded package | package | 69423-964 | 69423-964-08 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Menthol Cough Drops | MENTHOL COUGH DROPS | WHOLE FOODS MARKET, INC. | 1eb8927b-22c5-2ca3-e063-6294a90aa563 | 2024-08-02 | Warnings | M012 |
| No Drip Severe Anefrin Nasal | 0.05% OXYMETAZOLINE HCL | Walgreens Company | c126e969-56f3-47b4-a011-02ff150eccb8 | 2024-08-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 90e0426b-654f-4bcd-8b1d-cf56d1fc0c68 | 2024-07-27 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HCL | A-S Medication Solutions | 0e81a937-59e5-4869-8ffb-c758fb37230d | 2024-07-23 | Warnings | M012 |
| WesTussin DM | DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Westminster Pharmaceuticals, LLC | 68a0cd44-3fdd-430e-af1a-498d4415ab78 | 2024-07-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Lil' Drug Store Products, Inc. | edc244d6-eb0b-d3c9-e053-2a95a90a2622 | 2024-07-22 | Warnings | M012 |
| Night Time Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9 | 2024-07-22 | Warnings | M012 |
| CareOne Childrens Allergy Relief | DIPHENHYDRAMINE HCL | American Sales Company | bb78ef2c-4f42-4e8f-b38d-f9b2965a384b | 2024-07-19 | Warnings | M012 |
| dg health allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, LLC | 71445443-34bd-4d8c-b9c8-e7c3b8d4c832 | 2024-07-19 | Warnings | M012 |
| basic care childrens allergy relief | DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 75b9ee90-ad26-433e-8b90-97441b8d1e15 | 2024-07-19 | Warnings | M012 |
| Cold and Flu Severe Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC | 9b74dd00-8f84-4fce-b5ea-df886b595326 | 2024-07-18 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 4872dfdd-0df6-47ae-87f2-8049191cd482 | 2024-07-18 | Warnings | M012 |
| equate allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | b05acd16-21cb-4ee0-afa0-8f7d59166435 | 2024-07-18 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Publix Super Markets Inc | cc6e4e26-84f5-4003-b1eb-f0e06d3e294e | 2024-07-18 | Warnings | M012 |
| childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kroger Company | 10ebc7f8-dc8a-4640-8f87-d0d073998fd5 | 2024-07-18 | Warnings | M012 |
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | b173cc2c-7c4c-4f9e-a920-c71bc256ec1e | 2024-07-18 | Warnings | M012 |
| ALLERGY | CHLORPHENIRAMINE MALEATE | A-S Medication Solutions | b199b5ee-fff3-4746-be68-a04060586f8e | 2024-07-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | H E B | 2d1715b3-b1cf-455d-9909-f6d58c97db40 | 2024-07-18 | Warnings | M012 |
| careone allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | American Sales Company | ed4038fc-ab39-4567-9961-2b390b91b126 | 2024-07-17 | Warnings | M012 |
| Topcare childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 6b784cde-3152-4421-a825-dd1fc601aa7a | 2024-07-17 | 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 |