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 |
|---|---|---|---|---|---|---|
| Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 66543190-1d3d-4259-ae73-d366ecbf9e52 | 2026-05-12 | Warnings | M012 |
| basic care daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 612719a9-fa2e-4c40-8f35-a399aeaafecc | 2026-05-12 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 3cac44ad-1835-487e-b6d0-1483d724bb5e | 2026-05-12 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | 9cfb1abb-98c4-4e90-8dd7-fcffc112f988 | 2026-05-12 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab51b36-1c2e-4c97-932c-dacfaf55935a | 2026-05-11 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa | 2026-05-11 | Warnings | M012 |
| NebuClear MD | SALINE | Blue Echo Care LLC | 3f85fe62-230f-b0f1-e063-6394a90a5cb8 | 2026-05-11 | Warnings | M012 |
| Device - NebuClear MD Hand-held Rubber Bulb Nebulizer | DEVICE - HAND-HELD RUBBER BULB NEBULIZER | Blue Echo Care LLC | 43e0a646-be57-1024-e063-6394a90a43e4 | 2026-05-11 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1efd1778-7ab1-4797-98c5-4637940ee3ec | 2026-05-11 | Warnings | M012 |
| DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR | AptaPharma Inc. | 0380035e-44d5-44ea-9d1c-d57a1de65188 | 2026-05-10 | Warnings | M012 |
| Night Time Cold and Flu relief liquid filled softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE | AptaPharma Inc. | d61e2186-8b59-45f9-96ec-83430a0fe0cb | 2026-05-10 | Warnings | M012 |
| Maximum Strength Tussin DM Liquid filled Softgels | DEXTROMETHORPHAN HBR, GUAIFENESIN | AptaPharma Inc. | 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 | 2026-05-10 | Warnings | M012 |
| Day-Time Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c | 2026-05-10 | Warnings | M012 |
| Daytime Cold and Flu Relief Liquid Filled Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c078efb5-d30e-4dd1-a600-6e827390df76 | 2026-05-10 | Warnings | M012 |
| DM Max CONGESTION and COUGH | DEXTROMETHORPHAN HBR, GUAIFENESIN | DeMoulas Market Basket | b12e26b2-79e4-45a5-9a90-4630f92457d0 | 2026-05-09 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | fac55d76-457f-4258-9cc8-6edae539cada | 2026-05-08 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | HyVee Inc | 5a0ef8ae-f6d5-4388-b4da-6b7f025160b2 | 2026-05-08 | Warnings | M012 |
| Halls Variety Pack Mentholyptus Honey Lemon Cherry | MENTHOL | Mondelez Global LLC | 512a9a2e-6160-80d1-e063-6394a90aeff0 | 2026-05-08 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5150ff85-85bb-9cd9-e063-6294a90a1144 | 2026-05-08 | Warnings | M012 |
| Dr. Simi Children s Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Farmacias De Similares TX LLC | 5151740a-8270-7bb5-e063-6294a90ae387 | 2026-05-08 | 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 |