PRESGEN PEDIATRIC
- Product NDC
- 52083-653
- 11-digit product format
- 520830653
- Labeler code
- 52083
- Product ID
- 52083-653_6fa9d05a-47dd-4ede-b77b-ada155683617
- 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
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 75; 2.5 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
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 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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 | 52083-653-16 | 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
- PRESGEN PEDIATRIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 75 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 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 |
|---|---|
| 1119541 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-653-16 | 2025-11-18 | C162847 | 48780-1 | 2cef2736-b102-d83d-e063-dadaa90ab31f | PRESGEN PEDIATRIC |
| 52083-653-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b102-d83d-e063-dadaa90ab31f | PRESGEN PEDIATRIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-653-16 | PRESGEN PEDIATRIC | 480 mL in 1 BOTTLE | SYRUP | 480 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-653-16 | ML - Milliliter | 52083-653 | ddb3af58-cd6b-4248-aca4-547fb564a1f3 | 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 |
|---|---|---|---|---|---|---|
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 09286d15-b63f-a9de-e063-6294a90ab948 | 2023-11-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | eb64750f-19ac-655f-e053-2995a90a33b5 | 2023-11-02 | Warnings | M012 |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | M012 |
| Guaifenesin Syrup and Dextromethorphan | GUAIFENESIN SYRUP AND DEXTROMETHORPHAN | Natco Pharma USA LLC | ad9026f4-f0b6-4d02-aa44-f0460eeefc0e | 2023-11-01 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HYDROCHLORIDE | Natco Pharma USA LLC | 54b64354-ac10-42ff-a53d-96cef933a91a | 2023-11-01 | Warnings | M012 |
| children allergy relief dye free cherry | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 | 2023-11-01 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0903b222-1a44-64aa-e063-6294a90abba0 | 2023-10-31 | Warnings | M012 |
| Ephrine Nose Drops | PHENYLEPHRINE HYDROCHLORIDE | Walgreens | b620eb9f-2caf-0942-e053-2a95a90ae48e | 2023-10-31 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 204849d1-ac4b-4dbe-8769-fcb30291f880 | 2023-10-31 | Warnings | M012 |
| Daytime Cold and Flu Relief | DAYTIME COLD AND FLU RELIEF | TopCo Associates, LLC | d592fbb8-d4bf-444e-982e-edf6fe97dce4 | 2023-10-31 | Warnings | M012 |
| Nite Time Cold and Flu Relief | NITE TIME COLD AND FLU RELIEF | TopCo Associates, LLC | 407dc4ae-882d-4a49-8884-ef048bb404cf | 2023-10-31 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | Sheffield Pharmaceuticals LLC | cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 | 2023-10-30 | Warnings | M012 |
| Mucosa DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Magno-Humphries, Inc. | 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f | 2023-10-27 | Warnings | M012 |
| Mucosa Guifenesin | GUAIFENESIN | Magno-Humphries, Inc. | 9d22c208-d0ae-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M012 |
| DG Health Cough Drops Cherry Flavor | MENTHOL | Dollar General Corporation | c7a603d8-72fb-9626-e053-2995a90a09ea | 2023-10-26 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Geri-Care Pharmaceutical Corp | 92d90b41-0627-121e-e053-2995a90a2df1 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Cherry | MENTHOL | Riclan S.A. | 8e471265-3594-451a-8921-f0db474abe85 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Eucalyptus | MENTHOL | Riclan S.A. | 1141593a-f3ba-4adf-b332-f9fcb0b5a013 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Honey Lemon | MENTHOL | Riclan S.A. | f6271e85-9ca2-41d3-9bff-a13670ac5b80 | 2023-10-26 | 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 | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 6 |
| 1119541 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 6 |
| 1119541 | dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-653-16 | 52083065316 | 480 mL in 1 BOTTLE (52083-653-16) | 480 ml | 2011-03-24 | 0000-00-00 | No | No | Current |