Dover Sudanyl PE
- Product NDC
- 47682-162
- 11-digit product format
- 476820162
- Labeler code
- 47682
- Product ID
- 47682-162_3e4c212c-9fa3-9a39-e063-6294a90a7f2e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unifirst First Aid Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-12-30
- Marketing end
- 2027-08-31
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
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
- Dover Sudanyl PE
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1299145 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d7d62ac1-1333-4366-884b-26537766ce38 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-162-13 | Dover Sudanyl PE | 500 in 1 BOX | TABLET, FILM COATED | 500 | 13 | |
| 47682-162-99 | Dover Sudanyl PE | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47682-162 | MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241226_d7d62ac1-1333-4366-884b-26537766ce38.zip |
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 and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf911bf-eafe-fe46-e063-6294a90a3903 | 2024-07-03 | Warnings | M012 |
| Family Wellness Effervescent Cold Relief Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Family Dollar Services, Inc. | 4e13511b-fbb5-2523-e054-00144ff88e88 | 2024-07-03 | Warnings | M012 |
| Nighttime Cherry Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | TARGET CORPORATION | 1c3f6cbf-a00d-45b9-e063-6394a90a797c | 2024-07-02 | Warnings | M012 |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 |
| Halls Mentholyptus | MENTHOL | Mondelez Global LLC | f5292c5b-5608-4e13-afc2-4f3d7133da88 | 2024-06-25 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | 75638f29-7f2a-46b0-b8a0-e87bc7d6eba1 | 2024-06-25 | Warnings | M012 |
| Good Sense Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | A-S Medication Solutions | 5396a9cf-16eb-4628-9432-f49c67ffe2ce | 2024-06-25 | Warnings | M012 |
| Nighttime Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 130ca5f1-2951-ec6f-e063-6394a90a754f | 2024-06-24 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 08fd1513-30ab-15da-e063-6394a90ab57d | 2024-06-21 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 0c0caa59-0637-bc33-e063-6294a90ae244 | 2024-06-21 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | de401eb4-3282-4298-8a51-15d268253464 | 2024-06-21 | Warnings | M012 |
| Cough and Chest Congestion DM Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreens | e4515d0e-c12b-40cd-8218-6d91476cfebd | 2024-06-21 | Warnings | M012 |
| SUDOGEST | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 1811199f-bf88-475f-8f94-b372db4bead3 | 2024-06-20 | Warnings | M012 |
| Theraflu Severe Cold Relief Soft Chews | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 91dbb541-6a86-4803-a1fe-1bf61b457c34 | 2024-06-19 | Warnings | M012 |
| Tukol Max Action Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | aedce1f9-4902-4c51-92e0-6056196394c2 | 2024-06-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1299145 | phenylephrine HCl 5 MG Oral Tablet | PSN | d7d62ac1-1333-4366-884b-26537766ce38 | 13 |
| 1299145 | phenylephrine hydrochloride 5 MG Oral Tablet | SCD | d7d62ac1-1333-4366-884b-26537766ce38 | 13 |
| 1299145 | phenylephrine HCl 5 MG Oral Tablet | SY | d7d62ac1-1333-4366-884b-26537766ce38 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47682-162-13 | 47682016213 | 500 PACKET in 1 BOX (47682-162-13) / 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) | 500 packet | 2008-12-30 | 2027-08-31 | No | No | Current |
| 47682-162-99 | 47682016299 | 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) | 2008-12-30 | 2027-08-31 | No | No | Current |