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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 48438525-e49f-9303-e063-6394a90a44f2 | 2026-03-16 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, GUAIFENESIN | CVS HEALTH CORP | 4985c332-6602-fd2d-e063-6394a90accd2 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu and Nighttime Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 4981bbcd-7178-335f-e063-6394a90ae961 | 2026-03-16 | Warnings | M012 |
| Daytime and Nighttime | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 43da4211-3bb3-0a8e-e063-6294a90a4fcd | 2026-03-16 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 2026-03-14 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc | c0b36e4d-3667-58f6-e053-2a95a90afad7 | 2026-03-14 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | a16a85c2-e1fd-4d1a-a650-271ae430eb4f | 2026-03-14 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Kroger Company | ab12c975-2085-4365-9c4b-0be573a260c4 | 2026-03-13 | Warnings | M012 |
| Vicks SINEX SEVERE CONGESTION VapoCOOL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | 464550b3-5970-aca5-e063-6294a90a5954 | 2026-03-12 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Nice-Pak Products, LLC | ece10fdf-51f0-49ec-b38a-83f20203e0d8 | 2026-03-12 | Warnings, Adverse reactions | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | af35c833-316a-4d21-bd3a-9b71558cadbf | 2026-03-12 | Warnings | M012 |
| Allergy Relief Complete | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 88e3e51a-c9a5-43f9-b9d7-97509c607df1 | 2026-03-12 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCL | RB Health (US) LLC | 4cc490a6-a27a-a25b-e063-6294a90a3a95 | 2026-03-11 | Warnings | M012 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | 6207ef50-4f28-4dbc-9a52-f44dd53d2a4f | 2026-03-11 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c17a10a3-6b8f-4734-8f00-1f4c5c729725 | 2026-03-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | ba6d69ff-b392-4f21-b3d7-00d8ec5dee32 | 2026-03-11 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 67428f4b-28be-4682-a9a9-781bf85089ff | 2026-03-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HEB | 40091b98-b4c7-4a3b-e063-6294a90abd5d | 2026-03-10 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | United Natural Foods, Inc. dba UNFI | 0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da | 2026-03-10 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Topco Associates, LLC | 35305aa9-4fc1-4cda-b6f0-89df64f9eeff | 2026-03-10 | 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 |