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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 243fe8fc-996a-4855-8daf-069628e547c4 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | d310d170-5eeb-471b-af1a-0e845001d21d | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f454c289-5a31-4bd3-86a2-1281bf1ab14b | 2025-10-31 | Warnings, Adverse reactions | 04JA59TNSJ |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | c296efd0-5030-4a26-a9b0-e66423d995dc | 2025-10-31 | Warnings | 04JA59TNSJ |
| Daytime Cold and Flu Max Maximum Strength Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates, LLC | f7ebe482-cb22-4517-8463-3432cf60071d | 2025-10-31 | Warnings | 04JA59TNSJ |
| Nighttime Cold and Flu Max Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 787bff76-0ee2-4e7e-b908-876e4a3e3bfc | 2025-10-31 | Warnings | 04JA59TNSJ |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| QUALITY CHOICE Maximum Strength Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40416ff5-06e1-97dd-e063-6394a90a2046 | 2025-10-30 | Warnings | 04JA59TNSJ |
| GNP Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL | Amerisource Bergen | b0f0ef97-9add-717f-e053-2a95a90a0eb0 | 2025-10-30 | Warnings | 04JA59TNSJ |
| Normosol-R and Dextrose | DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | ead1fca3-eff4-478f-8a8f-67510f80151a | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | 04JA59TNSJ |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Hemorrhoid Anesthetic | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Universal Distribution Center LLC | 186c2d32-e8c5-d13d-e063-6294a90a2b0e | 2025-10-30 | Warnings | 04JA59TNSJ |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | 04JA59TNSJ |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | 04JA59TNSJ |
| Cold and Cough 4 Kids | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | e06599ca-fc94-4b2c-829e-f3d4ec866ed6 | 2025-10-29 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.