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 |
|---|---|---|---|---|---|---|
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 2025-11-15 | Warnings | M012 |
| Cold and Flu Day, Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | b9adfb5d-6576-4ff8-a7d7-a89b867c5292 | 2025-11-14 | Warnings | M012 |
| PECGEN DMX | DEXTROMETHORPHAN HBR, GUAIFENESIN | KRAMER NOVIS | a627824c-5e3d-4672-a047-6c801b50b432 | 2025-11-14 | Warnings | M012 |
| Supress DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | KRAMER NOVIS | 7da0611e-729c-4cf8-88f3-f8877b9f5cfa | 2025-11-14 | Warnings | M012 |
| G-ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc | 2025-11-14 | Warnings | M012 |
| Tussi Pres B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | d0afa44c-3acf-42a5-9889-4e9c10225256 | 2025-11-14 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | M012 |
| Guaifenesin 400mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13f4db4e-687e-9d7b-e063-6294a90ab088 | 2025-11-13 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13b8f480-d1ac-d70c-e063-6394a90ab4f4 | 2025-11-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | PD-Rx Pharmaceuticals, Inc. | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | M012 |
| Robitussin Maximum Strength Severe Cough Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 6a6f5da8-6433-4284-8df7-2d5b099b74dc | 2025-11-13 | Warnings | M012 |
| equaline allergy | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 8e4eb1eb-5b55-4531-94d2-998425ec80ed | 2025-11-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | 7a78f24b-7c23-4318-99dc-90c05db185b1 | 2025-11-13 | Warnings | M012 |
| ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 2025-11-13 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b6da1659-8c79-4cce-a817-907a7f061a2d | 2025-11-13 | Warnings | M012 |
| Tussi Pres | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 2025-11-12 | Warnings | M012 |
| 4 Way Fast Acting | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a8fc41c7-4425-41b8-b1c6-eb22ac054734 | 2025-11-12 | Warnings | M012 |
| Quality Choice Vapor Steam | CAMPHOR (SYNTHETIC) | Chain Drug Marketing Association, Inc. | 1f1e6be5-d407-330c-e063-6294a90a4e80 | 2025-11-12 | 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 |