Tussi Pres B
- Product NDC
- 52083-237
- Requested package NDC
- 52083-237-01
- 11-digit product format
- 520830237
- Labeler code
- 52083
- Product ID
- 52083-237_bcb683b0-64ea-42b3-9e04-ebbef60fbc33
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- KRAMER NOVIS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-29
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 20; 4; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 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
- Tussi Pres B
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| BROMPHENIRAMINE MALEATE | 4 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 52083-237-01 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-01 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-04 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-04 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-16 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-16 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-01 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-01 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-04 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-04 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-16 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-16 | 2025-01-30 | TUSSI PRES- B |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-237-01 | Tussi Pres B | 30 mL in 1 BOTTLE | SYRUP | 30 | 5 | |
| 52083-237-04 | Tussi Pres B | 120 mL in 1 BOTTLE | SYRUP | 120 | 5 | |
| 52083-237-16 | Tussi Pres B | 480 mL in 1 BOTTLE | SYRUP | 480 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-237-04 | ML - Milliliter | 52083-237 | 8a64cdb9-9a9f-495c-b009-18c0f607fc7d | 1 | 2012-07-24 |
| 52083-237-16 | ML - Milliliter | 52083-237 | 459d48b1-724f-43e0-9cfe-136520a619e5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52083-237 | TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS] | 4 | Current NDC, Legacy NDC, 3 package rows | 20191106_d0afa44c-3acf-42a5-9889-4e9c10225256.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 |
|---|---|---|---|---|---|---|
| Childrens PediaClear 8 | PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 8e524967-d01c-4c93-9198-c42f15fe3fe0 | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear PD | TRIPROLIDINE HYDROCHLORIDE | GM Pharmaceuticals, INC | f3ede5b7-1b0f-493a-b647-4459affc7e54 | 2025-10-03 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 | |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | Warnings | M012 |
| Acetaminophen and Diphenhydramine citrate | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | InvaTech Pharma Solutions LLC | 403a88fa-e06b-9b6e-e063-6394a90a97b8 | 2025-10-02 | Warnings | M012 |
| Equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | United Natural Foods, Inc. dba UNFI | 3053f6d7-0eff-488c-8901-770dcc62af06 | 2025-10-02 | Warnings | M012 |
| Rompe Pecho CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 401a97af-36ae-4e54-e063-6294a90ab3ee | 2025-10-01 | Warnings | M012 |
| NyQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | 724d0889-5ba5-3125-e053-2a91aa0a92c1 | 2025-10-01 | Warnings | M012 |
| DayQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 724f2833-34bd-6a9e-e053-2991aa0a073d | 2025-10-01 | Warnings | M012 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | InvaTech Pharma Solutions LLC | b8d360fa-0d80-f6a8-e053-2a95a90a8bd4 | 2025-10-01 | M012 | |
| LEADER TUSSIN CF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | f4ffe87b-0a62-44ac-b84a-08cf77cda7f5 | 2025-10-01 | Warnings | M012 |
| Nasal Spray, 1oz, 24/7 Life by 7-Eleven | OXYMETAZOLINE HCL NASAL SOLUTION 0.05% | Lil' Drug Store Products, Inc. | 3e781417-9ffc-f2c9-e063-6294a90a7205 | 2025-09-30 | Warnings | M012 |
| Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf | 2025-09-30 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3ff240ba-90b2-4c17-e063-6394a90ac56f | 2025-09-29 | Warnings | M012 |
| Dometuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 3fcace53-a81f-e774-e063-6294a90a32fa | 2025-09-27 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f6a3680a-3ac6-4fd4-be52-ce29064c4aa1 | 2025-09-26 | Warnings | M012 |
| No Drip Severe Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | 9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5 | 2025-09-26 | Warnings | M012 |
| Giltuss Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa0b3be-2124-ed1d-e063-6294a90aaf48 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3fa17255-514f-db47-e063-6294a90ae454 | 2025-09-25 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1148155 | brompheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | d0afa44c-3acf-42a5-9889-4e9c10225256 | 5 |
| 1148155 | brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | d0afa44c-3acf-42a5-9889-4e9c10225256 | 5 |
| 1148155 | brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | d0afa44c-3acf-42a5-9889-4e9c10225256 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-237-01 | 52083023701 | 30 mL in 1 BOTTLE (52083-237-01) | 30 ml | 2011-03-29 | 0000-00-00 | No | No | Current |