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_d5487434-8196-490e-90f9-ce09ce43c65d
- 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
- 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 | 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| BROMPHENIRAMINE MALEATE | 4 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| IXA7C9ZN03 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1148155 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d0afa44c-3acf-42a5-9889-4e9c10225256 | Available on FDA.report |
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 |
| 52083-237-04 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-16 | 2025-11-18 | TUSSI PRES- B |
| 52083-237-01 | 2025-01-30 | TUSSI PRES- B |
| 52083-237-04 | 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 |
|---|---|---|---|---|---|---|
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb | 2026-04-09 | Warnings | M012 |
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | e20b1093-d77f-4c39-b105-adaa1b82ea76 | 2026-04-09 | Warnings | M012 |
| Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 4f0c1b8e-3fb1-ccf2-e063-6394a90acd15 | 2026-04-09 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Lidl US LLC | b26ac105-f8e4-4ad0-8a26-9fdf30c01700 | 2026-04-09 | Warnings | M012 |
| Wal Dryl Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 09de28cd-fa60-4af7-b7cc-cf74c00a3531 | 2026-04-09 | Warnings | M012 |
| Tussin DM Max NIGHTTIME | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | d10a413e-22a6-4799-8367-5777831756a9 | 2026-04-09 | Warnings | M012 |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 80d25e23-b108-4eb1-88c7-73fe9da8f942 | 2026-04-09 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR AND GUAIFENESIN | L.N.K. International, Inc. | 2fea3533-8218-4875-affe-5b33a22c553a | 2026-04-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 2026-04-08 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | e24121d2-c9d2-4bbd-869e-eeed7e2bb881 | 2026-04-08 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 8460d4f9-8d7b-4ae4-8047-c2010d9c8013 | 2026-04-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | d2dab450-cf82-4be2-a4e2-630295fb59ab | 2026-04-08 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 4657c02b-887b-4746-8a78-83a72465e07b | 2026-04-08 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 33646fab-79a5-4f10-8ac0-48423eac9b56 | 2026-04-07 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 76e19b9a-3bdb-479a-9503-9e8250109c84 | 2026-04-07 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 7959ea00-2a41-4c3c-8c58-85795ebd2afc | 2026-04-06 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Preferred Pharmaceuticals Inc. | da148c1d-e394-4367-83e0-533469501b30 | 2026-04-06 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | TOP CARE (Topco Associates LLC) | b2ebfeb3-e248-40bf-81d3-81c5fb532dbe | 2026-04-06 | Warnings | M012 |
| Allergy Plus Sinus Relief | DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | Rite Aid Corporation | 54623e2e-5f9a-426e-8f7e-ea755ff8b3f8 | 2026-04-06 | 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 |