Severe Congestion and Cough
- Product NDC
- 59779-648
- Requested package NDC
- 59779-648-01
- 11-digit product format
- 597790648
- Labeler code
- 59779
- Product ID
- 59779-648_3aa97af2-b8af-4a71-98fc-3960dbb1f8da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-20
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10; 200; 5 mg/1; mg/1; mg/1
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 59779-648 | 59779-648-01 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Severe Congestion and Cough
- Brand name suffix
- Multi-Symptom Maximum Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1372652 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 707eb066-cdfc-444b-833a-9d6d133d48e4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-648-01 | Severe Congestion and CoughMulti-Symptom Maximum Strength | 3 in 1 PACKAGE | TABLET, FILM COATED | 3 | 16 | |
| 59779-648-01 | Severe Congestion and CoughMulti-Symptom Maximum Strength | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 16 | |
| 59779-648-95 | Severe Congestion and CoughMulti-Symptom Maximum Strength | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 16 | |
| 59779-648-95 | Severe Congestion and CoughMulti-Symptom Maximum Strength | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-648-01 | EA - Each | 59779-648 | 33cbd8ad-b767-419a-a108-092924cd5fcc | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-648 | SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY] | 15 | Current NDC, Legacy NDC, 4 package rows | 20240704_707eb066-cdfc-444b-833a-9d6d133d48e4.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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| CareOne Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e | 2026-08-04 | Warnings | M012 |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 3d8ce88e-9f40-4b58-a811-160ddbfb8112 | 2026-08-04 | Warnings | M012 |
| ValuRx Dye Free Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Shield Pharmaceuticals Corp | ca60a413-b02e-48ce-985d-4d415780c679 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 150b68ba-3ed4-4533-9118-74e76eaf6e48 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | ce393bff-498b-42e6-a41c-bbfbc58fb42c | 2026-08-04 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 3b8662bf-3abb-4e54-af9c-5fa1d2e19003 | 2026-08-04 | Warnings | M012 |
| Mucus Relief PE | GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cb1c1922-5dc6-520d-e77e-e951726d9701 | 2026-08-04 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | da053bc3-e790-4ae9-a406-2629640e97e7 | 2026-08-04 | Warnings | M012 |
| Cold and Flu plus Congestion Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALMART INC. | 1236b463-0073-44b5-a516-5b7c06a40887 | 2026-08-04 | Warnings | M012 |
| daytime nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 80aae1c3-a616-442b-842e-177db957a69c | 2026-08-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1372652 | dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 16 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 16 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | SY | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59779-648-01 | 59779064801 | 3 BLISTER PACK in 1 PACKAGE (59779-648-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2015-07-20 | 0000-00-00 | No | No | Current |