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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 1d6c23d7-d1dc-4cba-8600-5762c18a0e27 | 2026-01-29 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Belmora LLC | 3622e072-2784-c57e-e063-6394a90a8217 | 2026-01-29 | Warnings, Adverse reactions | M012 |
| Night Time Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | e7dd763b-3005-4723-933b-171eb772afee | 2026-01-29 | Warnings | M012 |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 24bc9ae6-8e8f-c0a0-e063-6394a90a407f | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | M012 |
| ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 4970b8bc-3c7b-4b8a-e063-6294a90a7f1b | 2026-01-28 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | fe3e74ba-31d9-4d50-ab61-ffb6aaa66085 | 2026-01-28 | Warnings | M012 |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | 9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 | 2026-01-28 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02 | 2026-01-27 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 53a3e6a7-d625-4393-95eb-bb6f86e86cc1 | 2026-01-27 | Warnings | M012 |
| Dextromethorphan Hbr,Guaifenesin | DEXTROMETHORPHAN HBR,GUAIFENESIN | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2fbbfc7c-81a9-b647-e063-6394a90a55ac | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 32074a31-326b-4aaf-e063-6394a90a0d40 | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 335b6ddd-fdc8-1120-e063-6394a90add41 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | Warnings | M012 |
| Sunscreen SPF50 | NON NANO ZINC OXIDE | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | c5d52f13-a649-9579-e053-2a95a90a062c | 2026-01-27 | Warnings | M012 |
| XL-3 Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rnv LLC | 03210929-331e-462d-b566-4e1865f52246 | 2026-01-27 | Warnings | M012 |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rnv LLC | 2381ff41-4584-4b38-839f-f94e733f5bf2 | 2026-01-27 | 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 |