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… |
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 |
|---|---|---|---|---|---|---|
| VICKS DayQuil SEVERE NyQuil SEVERE HONEY FLAVOR COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | fd03769c-2fd6-1c22-e053-6394a90a12f6 | 2025-10-03 | Warnings | M012 |
| VICKS FORMULA 44DM NIGHTTIME COUGH and COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE | Procter & Gamble Manufacturing Company | 05414779-f61d-8fa7-e063-6394a90aa034 | 2025-10-03 | Warnings | M012 |
| VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Procter & Gamble Manufacturing Company | 04ca1e9c-f297-cbd6-e063-6294a90a3739 | 2025-10-03 | Warnings | M012 |
| STAHIST AD | CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Magna Pharmaceuticals, Inc. | ccedbc38-2479-4c35-9f86-a9f29bcfab3f | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear 8 | PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 8e524967-d01c-4c93-9198-c42f15fe3fe0 | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear PD | TRIPROLIDINE HYDROCHLORIDE | GM Pharmaceuticals, INC | f3ede5b7-1b0f-493a-b647-4459affc7e54 | 2025-10-03 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil ELDERBERRY COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 1b569c65-437c-1dbc-e063-6394a90a04aa | 2025-10-03 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 | |
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | f4328b44-cdfa-41aa-e053-2995a90a2728 | 2025-10-02 | Warnings | M012 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efb5f0b9-9825-ab23-e053-2995a90a26ab | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb69cc1-a745-6efc-e053-2a95a90abdc9 | 2025-10-02 | Warnings | M012 |
| Vicks NyQuil Cough DM plus Congestion | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | c4d38921-ec90-0658-e053-2a95a90a848a | 2025-10-02 | Warnings | M012 |
| Vicks Formula 44 VapoCool Cough and Chest Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | The Procter & Gamble Manufacturing Company | d3bfce81-9e6d-6741-e053-2a95a90af183 | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil Kids Honey and Vicks NyQuil Kids Honey COLD and COUGH plus | DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efa53214-b2e0-cfd0-e053-2a95a90abbdf | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil Kids Cold Cough plus Mucus | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | c6f13d96-5136-63a0-e053-2a95a90af6dc | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil COLD and FLU | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | efb92829-1007-1c5d-e053-2a95a90a3c9b | 2025-10-02 | Warnings | M012 |
| Vicks DayQuil COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb982d4-93d0-815f-e053-2995a90a82dd | 2025-10-02 | Warnings | M012 |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | 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 |