Severe Congestion and Cough
- Product NDC
- 0363-6048
- 11-digit product format
- 003636048
- Labeler code
- 0363
- Product ID
- 0363-6048_0c6d06f5-d77a-4964-a7b4-5d16d5492c3f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Walgreen Company
- 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
- 2027-12-31
- 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 | 0363-6048 | 0363-6048-09 | D | Discontinued by firm | 2026-10-27 |
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… |
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
- Severe Congestion and Cough
- 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 |
|---|---|
| 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6048-09 | Severe Congestion and Cough | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 12 | |
| 0363-6048-09 | Severe Congestion and Cough | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | 12 | |
| 0363-6048-19 | Severe Congestion and Cough | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 12 | |
| 0363-6048-19 | Severe Congestion and Cough | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-6048 | SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240704_1ddc04fb-069c-44fe-814b-ba4f503c4be0.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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief Cold,Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | Wal-Mart Stores,Inc., | 2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc | 2025-10-27 | Warnings | M012 |
| Allergies MY CHILD NEEDS HELP WITH | DIPHENHYDRAMINE HCL | Unconditional Love | 5ad293e9-0a4b-4923-8a91-f01450726828 | 2025-10-27 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 4a9fd615-b7d3-452c-ac40-d9189124faaa | 2025-10-24 | Warnings | M012 |
| allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | 622b12fa-455c-4432-a9a2-698a929bbd68 | 2025-10-24 | Warnings | M012 |
| Dristan 12 hr | OXYMETAZOLINE HYDROCHLORIDE | Foundation Consumer Brands | 522876fe-a412-4ca8-bfad-a313e3cbc1af | 2025-10-24 | Warnings | M012 |
| Dimetapp Multi-Symptom Cold and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 178fe95b-e1ed-43b2-e063-6294a90a7a78 | 2025-10-24 | Warnings | M012 |
| Menthol Drops Dollar General Severe 45ct | MENTHOL | Dollar General Corporation | c831d3d9-b910-40e6-bfdf-defe6850614d | 2025-10-24 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 7d2f3292-bb73-41dc-9729-edb83670be1b | 2025-10-24 | Warnings | M012 |
| Freegells Cough Drops Menthol 30ct | MENTHOL | R.L. ALBERT & SON, INC | b174e57c-4e4f-4842-b8f2-f1b067764a68 | 2025-10-24 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 17640528-c1f7-4881-ba86-bb3f488a952c | 2025-10-24 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 33e259d6-b065-a677-e063-6394a90ab314 | 2025-10-23 | Warnings | M012 |
| Severe Nighttime Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 2025-10-23 | Warnings | M012 |
| Rycontuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 41afb883-1158-9764-e063-6294a90a1712 | 2025-10-21 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE | CVS Pharmacy, Inc | 1532ee21-e114-ded7-e063-6294a90ab025 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 1538bf63-d020-3ba2-e063-6294a90aecc5 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 312ce620-4841-7488-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Method Pharmaceuticals, LLC | 5a60c923-8bb7-427f-9636-08ed5474f71b | 2025-10-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 311e2b6b-21cb-4b4c-a78d-a0732d29602f | 2025-10-21 | 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 | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 12 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 12 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | SY | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-6048-09 | 00363604809 | 2 BLISTER PACK in 1 PACKAGE (0363-6048-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2015-07-20 | 0000-00-00 | No | No | Current |
| 0363-6048-19 | 00363604819 | 2 BLISTER PACK in 1 CARTON (0363-6048-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2023-07-18 | No | No | Current |