Desgen
- Product NDC
- 52083-641
- 11-digit product format
- 520830641
- Labeler code
- 52083
- Product ID
- 52083-641_ab452649-56eb-4ca6-8e30-03cfd2bcdb2e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
- Dosage form
- SOLUTION/ DROPS
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-27
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 50; 2.5 mg/mL; mg/mL; mg/mL
- 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
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-641-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-641-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-641-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-641-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-641-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-641-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-641-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-641-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Desgen
- Brand name suffix
- Pediatric
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/mL |
| GUAIFENESIN | 50 mg/mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/mL |
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 |
|---|---|
| 1095503 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-11-18 | Drug Facts |
| 2025-11-18 | DESGEN ® PEDIATRIC DROPS |
| 2025-01-30 | Drug Facts |
| 2025-01-30 | DESGEN ® PEDIATRIC DROPS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-641-01 | DesgenPediatric | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-641-01 | ML - Milliliter | 52083-641 | 5f35d6f8-b126-4d61-8fc4-60d780d01c4e | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Allergy Relief Extra Strength | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4f33c1fb-150b-4083-a9a4-c0fbab4b6133 | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 5ca7dc60-af0c-47c6-b453-8b39c744eb5b | 2026-01-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 2ce5f2af-cabc-466f-b0c5-256e6e6d4c88 | 2026-01-27 | Warnings | M012 |
| Sinus Headache and Pain Day, Non-drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | c33340c0-47d3-45e2-997b-3d9fb148900f | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | b7501b59-d25a-49ec-9cbf-47018bce8397 | 2026-01-27 | Warnings | M012 |
| good sense nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | f90bd64a-dd1a-4319-87cd-427d57f677ab | 2026-01-26 | Warnings | M012 |
| Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 547ff880-3d40-4a4a-84ee-cd0d5290a9b9 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Day and Night Cold and Flu | MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | WAL-MART STORES INC | d6a35fb8-1899-4da2-ad2b-0423e332845d | 2026-01-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Prodose, Inc. | 7e5de5b0-18f0-4807-8686-da9821f918ce | 2026-01-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | b9fbf917-12b7-770f-e053-2995a90afe93 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b58b2c36-a403-4dae-b3b2-f0ffd28a963b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 870e6bcb-84ab-45e0-ae57-08a9a182eb0b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | eb8e83a4-981b-48a5-88f4-3a0ba358d3bc | 2026-01-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 8d2d765f-a7e3-40e6-b35d-0e8806a7ea59 | 2026-01-26 | Warnings | M012 |
| NIGHTTIME COLD AND FLU CHERRY | PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Walgreen Company | 02a6781c-aa6f-8fb0-e063-6294a90a043d | 2026-01-26 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE | Walgreen Company | 02e5f475-4e9f-2856-e063-6294a90a21fd | 2026-01-26 | Warnings | M012 |
| GNP Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | AmerisourceBergen | 0bcc55bf-9654-120b-e063-6394a90a59d1 | 2026-01-26 | Warnings | M012 |
| S2 | RACEPINEPHRINE HYDROCHLORIDE | Nephron Pharmaceuticals Corporation | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 2026-01-26 | Warnings | M012 |
| SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d97c634-0975-42d5-8ade-2ed2018cfe9d | 2026-01-26 | Warnings | M012 |
| GOOD SENSE NIGHT TIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | L. Perrigo Company | cd68289b-3850-40c6-9439-aae0e2d7637d | 2026-01-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1095503 | dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution | PSN | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 5 |
| 1095503 | dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution | SCD | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 5 |
| 1095503 | dextromethorphan HBr 5 MG / guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Drops | SY | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-641-01 | 52083064101 | 30 mL in 1 BOTTLE, DROPPER (52083-641-01) | 30 ml | 2014-01-27 | 0000-00-00 | No | No | Current |