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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 445e49a2-6ed0-434c-aaea-3ce14bc7df59 | 2024-08-12 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | d49b42ad-0ae0-48c9-adba-5fc2ced97764 | 2024-08-12 | Warnings | M012 |
| RYMED | DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | c1d6e914-74cc-4cdf-9587-7eaaa4a386e5 | 2024-08-12 | Warnings | M012 |
| WesTussin DM NF | WESTUSSIN DM NF | Westminster Pharmaceuticals, LLC | 4e0f9f97-a31c-41ac-9d6c-d81efd20fcef | 2024-08-08 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2f2a2864-af11-4240-bdad-a54aca58d01b | 2024-08-07 | Warnings | M012 |
| Cold plus Flu Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0199aea2-a9c1-4c9d-8786-28b9dadc832e | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 32d1ce6e-2617-4b50-a9e6-2e1941465dff | 2024-08-07 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 07362db5-a372-4463-af8b-06e8783ca865 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1fb11d90-48bf-4baa-9b3a-5d64d81e3a06 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 574774b2-9813-4799-9cd4-27e296dd8584 | 2024-08-07 | Warnings | M012 |
| Cold Max Day and NIght | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | a92bcefb-ba29-4b3f-a60b-b4476ca8cf04 | 2024-08-07 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 778f1f5a-fd04-456f-90d0-998b93e774a5 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 990f3232-bc75-45cf-8a50-cd7861d83f98 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0f5f25c6-7389-4285-b8d5-463cb7b6fcc4 | 2024-08-07 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Care One (Retail Business Services, LLC.) | a9a5b39d-b4c8-414e-8fe7-4c0601f75197 | 2024-08-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 2024-08-04 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | 4cd8aee3-5522-434b-a1b1-9591bed3e9a6 | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 8632a655-7f5b-450f-95fa-62478a174e9c | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 990906b3-c566-4f35-923c-060202ba48e0 | 2024-08-04 | Warnings | M012 |
| Honey Lemon Flavor Cough Drops | HONEY LEMON FLAVOR MENTHOL | WHOLE FOODS MARKET, INC. | 1eb7abdc-061f-0e18-e063-6294a90a3a65 | 2024-08-02 | 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 |