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 |
|---|---|---|---|---|---|---|
| VANACOF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | 2ed699f2-d004-4fa9-8042-6c85a9ff69b6 | 2025-11-03 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | VERITYRX, LLC | 42a05f69-0599-5571-e063-6394a90a37d3 | 2025-11-02 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | VERITYRX, LLC | 42a0e577-a1b6-2c16-e063-6294a90af8e3 | 2025-11-02 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | c296efd0-5030-4a26-a9b0-e66423d995dc | 2025-10-31 | Warnings | M012 |
| Daytime Cold and Flu Max Maximum Strength Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates, LLC | f7ebe482-cb22-4517-8463-3432cf60071d | 2025-10-31 | Warnings | M012 |
| Nighttime Cold and Flu Max Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 787bff76-0ee2-4e7e-b908-876e4a3e3bfc | 2025-10-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Trader Joe's Company | 647dadae-f37a-8399-e053-2991aa0aedb3 | 2025-10-31 | Warnings | M012 |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40416ff5-06e1-97dd-e063-6394a90a2046 | 2025-10-30 | Warnings | M012 |
| Robitussin Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 2025-10-30 | Warnings | M012 |
| Robitussin Day and Night Cough Relief DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b3d02c91-8f79-4eb4-a378-1072474c572c | 2025-10-30 | Warnings | M012 |
| ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7 | 2025-10-30 | Warnings | M012 |
| Endal | TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR | Poly Pharmaceuticals, Inc. | fc5401e2-ed65-72e7-e053-6294a90a81f3 | 2025-10-30 | Warnings | M012 |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | SAM'S WEST INC | 16592ad7-b7cb-0837-e063-6394a90ae059 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | M012 |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | M012 |
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | M012 |
| Dollar General Vapor Steam | CAMPHOR (SYNTHETIC) | DOLGENCORP, LLC | 86d0f3ac-1359-c2f9-e053-2a91aa0a35d0 | 2025-10-29 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 5d628b09-c257-4369-8ddb-47554d83c0d8 | 2025-10-29 | Warnings | 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 |