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
- 2027-12-31
- 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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Topcare childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 6b784cde-3152-4421-a825-dd1fc601aa7a | 2024-07-17 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 4c6b6379-3a7f-4507-a792-7b69a7f3ba82 | 2024-07-17 | Warnings | M012 |
| Mucus Relief Cold Flu Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 04defcf6-e20e-402b-b725-d9394a0146b1 | 2024-07-16 | Warnings | M012 |
| basic care allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 7d237d37-21c7-476d-a8b7-d91ea1b472ee | 2024-07-16 | Warnings | M012 |
| Berkley and Jensen Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC | b52fc311-8853-4116-941b-8be35456abba | 2024-07-16 | Warnings | M012 |
| Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | 0b9a4438-7d13-484c-a614-2dedc24974dc | 2024-07-16 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Publix Super Markets Inc | 23a98385-28cc-4fac-8c87-b3ced8106532 | 2024-07-16 | Warnings | M012 |
| Walgreens Moisturizing Ultra Fine Mist with Aloe | 0.05% OXYMETAZOLINE | Walgreens Company | aad01028-cbe0-4c10-adbc-d157bfa5af09 | 2024-07-16 | Warnings | M012 |
| Basic Care severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 924bf427-b054-46af-b341-ff162946cd58 | 2024-07-15 | Warnings | M012 |
| Maximum Strength Cold Tabs | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | JHK DBA American Safety & First Aid | e7d4fe9a-eb09-4266-90c9-290f61ce6ad0 | 2024-07-15 | Warnings | M012 |
| ACTIDOM DA | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 | 2024-07-15 | Warnings | M012 |
| Nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1cf3064d-4ddd-63b9-e063-6294a90aa547 | 2024-07-11 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1ccbdb53-3f70-28da-e063-6394a90a9ae0 | 2024-07-09 | Warnings | M012 |
| AXIV Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1cd2a6f1-31ad-e507-e063-6394a90aba58 | 2024-07-09 | Warnings | M012 |
| Poly Hist Forte | DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 | 2024-07-09 | Warnings | M012 |
| DECONEX DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aab8e5c-1633-2e5a-e053-2a95a90adcc5 | 2024-07-09 | Warnings | M012 |
| Deconex IR | GUAIFENESIN AND PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | 4710095e-3dae-4a39-8a98-873012e1f003 | 2024-07-09 | Warnings | M012 |
| Diabetic Tussin Sore Throat and Cough Cherry | BENZOCAINE AND DEXTROMETHORPHAN HBR | MEDTECH PRODUCTS INC | e9327079-e0fc-4c95-b1d5-bc1b74870c9b | 2024-07-09 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | fac859a4-e23a-4879-af6c-26368455506d | 2024-07-05 | Warnings | M012 |
| Severe Throat Drops | MENTHOL ICE | Target Corporation Inc. | 1876b221-fa60-5269-e063-6394a90a6963 | 2024-07-04 | 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 |