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 |
|---|---|---|---|---|---|---|
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | f49f1e9a-07ac-443e-9df8-3281d5f35e78 | 2026-03-03 | Warnings | M012 |
| berkley and jensen nasal | OXYMETAZOLINE HYDROCHLORIDE | BJWC | 77cbe75d-4ed9-4a8b-91dc-1cc28af25508 | 2026-03-02 | Warnings | M012 |
| childrens cold and cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Walgreen Company | 6c7c950d-ed48-4428-9e9e-73684cabc699 | 2026-02-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Kroger Co. | 116146db-719f-4c48-8a8a-1120ea62b0d5 | 2026-02-27 | Warnings, Adverse reactions | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 1f737b76-14b5-618a-e063-6294a90a19c2 | 2026-02-27 | Warnings | M012 |
| WALGREENS NIGHTTIME ALLERGY RELIEF | DOXYLAMINE SUCCINATE | WALGREENS CO. | a3c7df98-4611-4b61-9c03-5e687364bf74 | 2026-02-27 | Warnings | M012 |
| MEIJER Childrens Allergy Relief Chews | DIPHENHYDRAMINE HCL | MEIJER DISTRIBUTION INC | 3368e081-a3b2-4c03-8bd1-05cc6af0391d | 2026-02-27 | Warnings | M012 |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | M012 |
| Tussin DM Cough and Chest | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 402969c9-945c-44b7-b018-b62f427ce571 | 2026-02-26 | Warnings | M012 |
| nasal original | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | d997f264-1b4a-4cca-a282-bd9645d55bfd | 2026-02-26 | Warnings | M012 |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | M012 |
| Cough and Chest Congestion DN, Cough DM Daytime, Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 184059b7-9238-480e-be4a-ed105f13c19d | 2026-02-25 | Warnings | M012 |
| Kids Daytime Cough and Nighttime Cough combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Genexa Inc. | 4bad39f1-86d4-b8a1-e063-6394a90a7a95 | 2026-02-25 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 67072a38-1ae7-4e59-bfed-71db0d93215d | 2026-02-25 | Warnings | M012 |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 | 2026-02-25 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Family Dollar Stores, Inc | 1b50b865-3dfc-4b3f-86d5-5e91ca772445 | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Vaproizing | CAMPHOR | H E B | 577fda09-588a-4c2e-ada5-eeda32d1aabe | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Sore Throat Logenzes Sore Throat | BENZOCAINE AND MENTHOL | Major Pharmaceuticals | 11416620-4892-44ba-9780-db27efff6743 | 2026-02-24 | Warnings | M012 |
| Family Wellness SF Honey Lemon Cough Drops | MENTHOL | Family Dollar | 4437853d-1f42-a41d-e063-6294a90aa81e | 2026-02-24 | 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 |