TUSSI PRES PEDIATRIC
- Product NDC
- 52083-232
- 11-digit product format
- 520830232
- Labeler code
- 52083
- Product ID
- 52083-232_f4ed6319-294a-4fd8-baaf-0ffec7c6a0ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- KRAMER NOVIS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-24
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 75; 2.5; 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
- 2027-12-31
- 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 | 52083-232 | 52083-232-01 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 52083-232 | 52083-232-04 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 52083-232 | 52083-232-05 | 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 | 52083-232-04 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52083-232-01 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52083-232-05 | 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 | 52083-232-16 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-232-05 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-232-04 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 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 | 52083-232-16 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-232-05 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-232-04 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 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 | 52083-232-16 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-232-05 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-232-04 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 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 | 52083-232-16 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-232-05 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-232-04 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 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 | 52083-232-16 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-232-05 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-232-04 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 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 | 52083-232-05 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-232-04 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-232-16 | 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 | 52083-232-05 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-232-04 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-232-01 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-232-16 | 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 | 52083-232-05 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-232-04 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-232-16 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52083-232-05 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52083-232-04 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52083-232-01 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52083-232-05 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52083-232-04 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52083-232-01 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52083-232-05 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52083-232-04 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52083-232-01 | 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 PEDIATRIC
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 75 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 52083-232-01 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-01 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-04 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-04 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-05 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-05 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-16 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-16 | 2025-11-14 | TUSSI PRES PEDIATRIC |
| 52083-232-01 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-01 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-04 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-04 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-05 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-05 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-16 | 2025-01-30 | TUSSI PRES PEDIATRIC |
| 52083-232-16 | 2025-01-30 | TUSSI PRES PEDIATRIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-232-01 | TUSSI PRES PEDIATRIC | 30 mL in 1 BOTTLE | SYRUP | 30 | 6 | |
| 52083-232-04 | TUSSI PRES PEDIATRIC | 120 mL in 1 BOTTLE | SYRUP | 120 | 6 | |
| 52083-232-05 | TUSSI PRES PEDIATRIC | 5 mL in 1 BOTTLE | SYRUP | 5 | 6 | |
| 52083-232-16 | TUSSI PRES PEDIATRIC | 480 mL in 1 BOTTLE | SYRUP | 480 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-232-04 | ML - Milliliter | 52083-232 | 06ef9126-dc33-47c2-b09e-ea509f104b47 | 1 | 2013-02-13 |
| 52083-232-05 | ML - Milliliter | 52083-232 | c20a5746-f081-4a2d-a499-6aabc63ffadf | 1 | 2018-12-13 |
| 52083-232-16 | ML - Milliliter | 52083-232 | 65b6b6cc-9223-4f33-b2e9-4ef90823c2c9 | 1 | 2013-02-13 |
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 |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | The Kroger CO | f6da2e02-42c7-1ede-e053-6394a90aff5f | 2025-02-09 | Warnings | M012 |
| MUCOSA DM | GUAIFENESIN DEXTROMETHORPHAN | TIME CAP LABORATORIES, INC. | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 2025-02-08 | Warnings | M012 |
| Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | 2d95d5a4-34dc-e195-e063-6394a90a39da | 2025-02-07 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f40bfdfc-1cb4-4604-9790-fb8d1d5173c6 | 2025-01-31 | Warnings | M012 |
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Bryant Ranch Prepack | 7b23faa9-40c8-4cea-b9fb-487cce2664af | 2025-01-31 | Warnings | M012 |
| BENADRYL Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 224ba2a3-1a93-29c8-e063-6394a90a9bef | 2025-01-30 | Warnings | M012 |
| Extra Strength Nite-Time Pain Relief | 430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET | WALGREENS | c25cff5a-93f5-62aa-e053-2a95a90aa7b4 | 2025-01-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALGREENS | dbf5c814-4e69-13ac-e053-2a95a90a49a3 | 2025-01-30 | Warnings | M012 |
| Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | WALGREENS | f3770976-de73-52b8-e053-2995a90aad4f | 2025-01-30 | Warnings | M012 |
| Dextromethorphan HBr and Guaifenesin Oral Solution | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION | KESIN PHARMA CORPORATION | 284eae44-81bc-400c-e063-6394a90af446 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26c82bc3-5753-4d56-96a4-a3f9c8c267d0 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8095b211-8ae7-44e5-b89a-b7f730e28d51 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 | 2025-01-30 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy, Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 | 2025-01-30 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1119541 | dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 6 |
| 1119541 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 6 |
| 1119541 | dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-232-01 | 52083023201 | 30 mL in 1 BOTTLE | 30 ml | Historical | ||||
| 52083-232-04 | 52083023204 | 120 mL in 1 BOTTLE | 120 ml | Historical | ||||
| 52083-232-05 | 52083023205 | 5 mL in 1 BOTTLE (52083-232-05) | 5 ml | 2012-01-21 | 0000-00-00 | No | No | Current |
| 52083-232-16 | 52083023216 | 480 mL in 1 BOTTLE (52083-232-16) | 480 ml | 2011-03-24 | 0000-00-00 | No | No | Current |