Tussi Pres
- Product NDC
- 52083-231
- 11-digit product format
- 520830231
- Labeler code
- 52083
- Product ID
- 52083-231_15192bad-05a9-4d18-9604-db4122f47aad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-28
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 52083-231 | 52083-231-04 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 52083-231 | 52083-231-10 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52083-231-10 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52083-231-04 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 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 | 52083-231-10 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-231-04 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-231-04 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-231-04 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-231-04 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-231-04 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-231-04 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-231-04 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-231-16 | 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 | 52083-231-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-231-04 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-231-16 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52083-231-10 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52083-231-04 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52083-231-10 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52083-231-04 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52083-231-10 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52083-231-04 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 200 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1098647 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0d4ee530-2a5c-41a0-88bf-ac92d538661b | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 52083-231-04 | 2025-11-18 | TUSSI-PRES |
| 52083-231-10 | 2025-11-18 | TUSSI-PRES |
| 52083-231-16 | 2025-11-18 | TUSSI-PRES |
| 52083-231-04 | 2025-01-30 | TUSSI-PRES |
| 52083-231-10 | 2025-01-30 | TUSSI-PRES |
| 52083-231-16 | 2025-01-30 | TUSSI-PRES |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-231-04 | Tussi Pres | 120 mL in 1 BOTTLE | SYRUP | 120 | 5 | |
| 52083-231-10 | Tussi Pres | 10 mL in 1 PACKET | SYRUP | 10 | 5 | |
| 52083-231-16 | Tussi Pres | 480 mL in 1 BOTTLE | SYRUP | 480 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-231-04 | ML - Milliliter | 52083-231 | 0d927646-59e4-4cbc-aca6-1231215f46ab | 1 | 2012-07-24 |
| 52083-231-10 | ML - Milliliter | 52083-231 | 425c0a76-d6cd-49c0-b985-610536b75429 | 1 | 2013-02-13 |
| 52083-231-16 | ML - Milliliter | 52083-231 | 7aff57c5-ff9e-4382-ae31-880dd2da30b5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| TARGET Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | bfc91c71-0506-4e94-8bfe-dc9e4bf959da | 2025-11-07 | Warnings | M012 |
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | H E B | 08f4785a-c628-4e9b-9412-b2a817f9be60 | 2025-11-07 | Warnings | M012 |
| G-TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | d169585f-b4f4-4831-8c71-e1533ae7e7c4 | 2025-11-07 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | M012 |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | M012 |
| Sinus Congestion | PSEUDOEPHEDRINE HCL | Chain Drug Marketing Association, Inc. | 9744d04d-298d-4acd-9470-db9e7f2901e7 | 2025-11-07 | Warnings | M012 |
| Daytime, Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 | 2025-11-07 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e | 2025-11-07 | Warnings | M012 |
| Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | ff0bffee-9a36-8246-e053-6294a90a86c7 | 2025-11-06 | Warnings | M012 |
| Xlear Nasal Decongestant | NASAL SPRAY | Xlear Inc. | 1c1db71a-47d0-42ac-8cbe-95e76dca185f | 2025-11-06 | Warnings | M012 |
| Robitussin Honey Cough DM Day Night Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 1bbd0157-06e6-4a3b-bac9-91ac879ba089 | 2025-11-06 | Warnings | M012 |
| ValuMeds Nasal Decongestant Phenylephrine HCl | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 21676b0c-6be2-464c-ae91-92e5f0d0087d | 2025-11-06 | Warnings | M012 |
| COLD AND FLU SEVERE Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 04715af5-e861-496c-834a-233eb7312556 | 2025-11-06 | Warnings | M012 |
| Severe Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 2025-11-06 | Warnings | M012 |
| Target Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 05e944d5-3473-4d8c-8df4-2ffc7474e9fa | 2025-11-05 | Warnings | M012 |
| Target Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | TARGET CORPORATION | e36f179e-5aed-4fee-8b0a-767bf3590752 | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | M012 |
| Up and Up maximum Strength fast mucus relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | f007beaa-b108-46d5-8a98-853f011a8e2e | 2025-11-05 | Warnings | M012 |
| Target Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | TARGET CORPORATION | 975e157a-8f8d-41ad-b55b-9f9100188ccd | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL | TARGET CORPORATION | 6e94fdab-27ea-4c0f-a91c-735ce697304b | 2025-11-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1098647 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 5 |
| 1098647 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 5 |
| 1098647 | dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 5 |
| 1098647 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-231-04 | 52083023104 | 120 mL in 1 BOTTLE | 120 ml | Historical | ||||
| 52083-231-10 | 52083023110 | 10 mL in 1 PACKET (52083-231-10) | 10 ml | 2011-03-28 | 0000-00-00 | No | No | Current |
| 52083-231-16 | 52083023116 | 480 mL in 1 BOTTLE (52083-231-16) | 480 ml | 2011-03-28 | 0000-00-00 | No | No | Current |