GENCONTUSS
- Product NDC
- 52083-650
- 11-digit product format
- 520830650
- Labeler code
- 52083
- Product ID
- 52083-650_8a52f9ca-43f9-4f88-ae67-2ee6e1541d51
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- KRAMER NOVIS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-08
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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 | 52083-650-16 | 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
- GENCONTUSS
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 2 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1363752 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 69d16d25-b09b-430e-8e01-0962d840dc21 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-11-14 | GENCONTUSS |
| 2025-11-14 | GENCONTUSS ® |
| 2025-01-30 | GENCONTUSS |
| 2025-01-30 | GENCONTUSS ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-650-16 | GENCONTUSS | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-650-16 | ML - Milliliter | 52083-650 | 06ae7d11-09ed-4531-ad88-041ec9f515c2 | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52083-650 | GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20221029_69d16d25-b09b-430e-8e01-0962d840dc21.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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Cherry Cough Drops | MENTHOL | McKesson | 49eefa70-cef9-d7ec-e063-6294a90ac321 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive Honey Lemon Cough Drops | MENTHOL | McKesson | 49f13ee3-6bb3-e500-e063-6394a90a152d | 2026-02-03 | Warnings | M012 |
| Daytime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive SF Honey Lemon Cough Drops | MENTHOL | McKesson | 49f41c30-f806-44ba-e063-6394a90a5a67 | 2026-02-03 | Warnings | M012 |
| Nighttime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853 | 2026-02-03 | Warnings | M012 |
| allergy relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f | 2026-02-03 | Warnings | M012 |
| Cold and Allergy D | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 832ac849-7f4a-489a-a704-9d4388a75a71 | 2026-02-03 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 987f908b-7af7-4705-bfb4-c48d771c380d | 2026-02-03 | Warnings | M012 |
| tussin dm nighttime max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 1f3fb451-84c9-432e-ac67-2694dd66c815 | 2026-02-03 | Warnings | M012 |
| Robafen DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Major Pharmaceuticals | 7c9660b7-cb00-449b-b65f-aa42d8ce1942 | 2026-02-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 6b0d261f-fc27-4b34-88b1-cd3d72766760 | 2026-02-02 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | ebfcb699-3369-4697-9841-44015b1c9808 | 2026-02-02 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE, MENTHOL | Meijer Distribution Inc. | 2f6de590-7cad-25d7-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough lozenge | DEXTROMETHORPHAN HYDROBROMIDE | Meijer Distribution, Inc. | 304ff4db-201a-60a4-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Allergy Relief Plus Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 38d91107-d95c-40f2-a27e-561f951e519d | 2026-02-02 | Warnings | M012 |
| Tussin Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 85252999-3463-45fe-b4a9-7a97960b41b1 | 2026-02-02 | Warnings | M012 |
| Amazon Basics Cherry Cough Drops 30ct | MENTHOL | Amazon | 3e74e209-c9c9-3979-e063-6294a90afcfa | 2026-02-01 | Warnings | M012 |
| Amazon Basics Honey Lemon Cough Drops 30ct | MENTHOL | Amazon | 3e75838b-e1c9-2d42-e063-6294a90aab82 | 2026-02-01 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 5110526f-51fd-401e-ba52-520674d34f37 | 2026-02-01 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Amazon.com Service LLC | 673996ab-6e57-4feb-8af3-d8b474741a8d | 2026-01-30 | Warnings, Adverse reactions | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution | PSN | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
| 1363752 | chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-650-16 | 52083065016 | 473 mL in 1 BOTTLE, PLASTIC (52083-650-16) | 473 ml | 2015-06-08 | 0000-00-00 | No | No | Current |