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 |
|---|---|---|---|---|---|---|
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 2025-06-09 | Warnings | M012 |
| Equate Kids Daytime Dex Cough Gels | DEXTROMETHORPHAN | Walmart | 37269cd6-1528-9879-e063-6394a90a2b54 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | bdc35570-c8df-4797-a13e-7f2479ec42b7 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | f5764925-c586-40e4-8252-24d92389af01 | 2025-06-09 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 7fa8e4ad-95cb-4905-90db-d53b3bc87c41 | 2025-06-09 | Warnings | M012 |
| Vaporizing Steam Liquid | MEDICATED COUGH SUPPRESSANT | NeilMed Pharmaceuticals Inc. | 36cf6218-adb8-9d8b-e063-6394a90a49a0 | 2025-06-05 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 7e2fb43c-a7f1-4c1d-a700-7c6510999c03 | 2025-06-05 | Warnings | M012 |
| CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | Haleon US Holdings LLC | becb4025-b63e-f2ea-9d11-d51fdf4e5c13 | 2025-06-04 | Warnings | M012 |
| Diphenhydramine HCL STRAWBERRY FLAVOR | DIPHENHYDRAMINE HCL | Innovida Pharmaeutique Corporation | 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf | 2025-06-04 | Warnings | M012 |
| Children Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | TARGET CORPORATION | 69d33f77-06e1-48fa-a516-892fdf11bb1c | 2025-06-03 | Warnings | M012 |
| oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fd058e2b-5445-e416-e053-6394a90a611b | 2025-06-03 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 36b1a7e0-c8b9-0890-e063-6394a90ab13a | 2025-06-03 | Warnings | M012 |
| COLD, FLU and SORE THROAT RELIEF | ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG | BETTER LIVING BRANDS, LLC | 202d60a8-83da-5afc-e063-6394a90ad779 | 2025-05-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | TARGET CORPORATION | f935341f-1e33-d78e-e053-6294a90a348e | 2025-05-30 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | AARNA USA INC. | 365bb414-8425-a900-e063-6394a90aa887 | 2025-05-30 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 8559be55-8b00-4353-8e26-b5dff2ada806 | 2025-05-30 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walmart Inc. | 35da8429-1f83-9e81-e063-6294a90a3515 | 2025-05-23 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9dfef3dc-dbc8-659a-e053-2995a90a8c3b | 2025-05-21 | Warnings | M012 |
| Adult Tussin | GUAIFENESIN | Camber Consumer Care | 896d2540-279a-4405-b176-acbff56303e5 | 2025-05-20 | 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 |