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 |
|---|---|---|---|---|---|---|
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | M012 |
| tussin dm max daytime nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN | CVS Pharmacy | 6feaf29e-de06-4c94-912c-a76ea2cbd8c1 | 2024-12-16 | Warnings | M012 |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | M012 |
| Dextromethorphan HBr 15 mg Liquid Gels | DEXTROMETHORPHAN HBR | RUGBY LABORATORIES | cf3cc387-6642-43fd-999d-688fdaf65d4f | 2024-12-14 | Warnings | M012 |
| Allergy Relief Dye-Free Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 60b1bb79-3ed1-438b-a27f-f7fbc108d114 | 2024-12-14 | Warnings | M012 |
| Rycontuss Cherry Flavor | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Okendpharma, Inc. | c91798fa-48ab-47a0-92da-4d44c2aafde0 | 2024-12-13 | Warnings | M012 |
| Mentholatum Lavender Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 6f208c05-617d-492a-a016-e9d6be3c971f | 2024-12-13 | Warnings | M012 |
| CVS Vapor Steam | CAMPHOR (SYNTHETIC) | CVS | 49da2c40-afc5-5770-e054-00144ff88e88 | 2024-12-13 | Warnings | M012 |
| Kroger Daytime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Company | e428dd83-c538-2a92-e053-2a95a90a0e16 | 2024-12-13 | Warnings | M012 |
| Kroger Nighttime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Company | e46291c7-6f4d-46a2-e053-2a95a90a80a1 | 2024-12-13 | Warnings | M012 |
| Foster and Thrive Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 7eaba464-5cdb-4bd4-b272-38fa108658d5 | 2024-12-13 | Warnings | M012 |
| SUDAFED OM Sinus Severe Original | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 1d089074-3969-ce6e-e063-6294a90aa70c | 2024-12-12 | Warnings | M012 |
| RIGHT REMEDIES Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc | b4fc014c-7c5f-46a4-bf13-57103b6fa018 | 2024-12-11 | Warnings | M012 |
| Diphenhydramine Hydrochloride 25mg | DIPHENHYDRAMINE HYDROCHLORIDE 25MG | Strive Pharmaceuticals Inc | b440eb2e-4de9-2b65-e053-2995a90abda8 | 2024-12-11 | Warnings | M012 |
| Meijer Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Meijer Distribution Inc. | 6933ca9d-a32d-d856-e053-2a91aa0a408e | 2024-12-10 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Meijer Distribution Inc. | 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 | 2024-12-10 | Warnings | M012 |
| DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC | MENTHOL | Ricola USA Inc. | 09141018-37ba-4c93-9051-1ed129c448c1 | 2024-12-10 | Warnings | M012 |
| Original Herb Cough Drops | MENTHOL | Ricola USA Inc. | 6ac9d95b-f6b9-4515-b126-697f8f839612 | 2024-12-10 | Warnings | M012 |
| THE ORIGINAL NATURAL HERB COUGH DROPS | MENTHOL | Ricola USA Inc. | 989d1529-2875-47bf-81df-65494d62be7a | 2024-12-10 | 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 |