NDC 70069-591-01 - Phenylephrine Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 70069-591
- Requested NDC
- 70069-591-01
- Package NDCs from labels
- 70069-591-01, 70069-591-10
- Manufacturer
- Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited
- Effective date
- 2025-03-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Phenylephrine Hydrochloride - Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | 2025-03-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70069-591-01 | Phenylephrine Hydrochloride | 5 mL in 1 AMPULE | SOLUTION | 5 | 7 | |
| 70069-591-10 | Phenylephrine Hydrochloride | 10 in 1 CARTON | SOLUTION | 10 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-591-01 | ML - Milliliter | 70069-591 | f273d1be-f3df-418b-9657-fee8baad1d25 | 1 | 2025-10-14 |
| 70069-591-10 | ML - Milliliter | 70069-591 | 554a221f-8efa-45ff-9338-fc8a2ce86782 | 1 | 2025-10-14 |
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 |
|---|---|---|---|---|---|---|
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | 04JA59TNSJ |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | 04JA59TNSJ |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | 04JA59TNSJ |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c3f358dd-4a36-4808-9943-e01f88604be5 | 2024-04-10 | Warnings, Adverse reactions | 04JA59TNSJ |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Hers Plus | CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | Deseret Biologicals,Inc. | e4636b80-f6c8-459c-8d0e-ff7801358b10 | 2024-04-09 | Warnings | 451W47IQ8X |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | 04JA59TNSJ |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | 04JA59TNSJ |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | 04JA59TNSJ |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | 04JA59TNSJ |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | 04JA59TNSJ |
| Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 89360fa8-014d-4da8-bb1c-197e3aa52256 | 2024-04-06 | Warnings | 04JA59TNSJ |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | 04JA59TNSJ |
| Robitussin Peak Cold Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 8c0a2424-e8ac-d91c-b46d-a5ee29f91936 | 2024-04-06 | Warnings | 04JA59TNSJ |
| Preparation H Cooling Gel | PHENYLEPHRINE HCL, WITCH HAZEL | Haleon US Holdings LLC | cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4 | 2024-04-05 | Warnings | 04JA59TNSJ |
| PREPARATION H Maximum Strength | GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL | Haleon US Holdings LLC | 7cc03d2e-e708-589a-d9bb-58ebbda989c0 | 2024-04-05 | Warnings | 04JA59TNSJ |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | 04JA59TNSJ |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.