NDC 0641-6188-01 - 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
- 0641-6188
- Requested NDC
- 0641-6188-01
- Package NDCs from labels
- 0641-6188-01, 0641-6188-10
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Effective date
- 2026-08-19
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Phenylephrine Hydrochloride - Hikma Pharmaceuticals USA Inc. | Hikma Pharmaceuticals USA Inc. | 2026-08-19 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6188-01 | Phenylephrine Hydrochloride | 5 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 5 | 12 | |
| 0641-6188-10 | Phenylephrine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0641-6188 | PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6188-01 | ML - Milliliter | 0641-6188 | 0d8aac8b-9871-4eee-aad5-d748056e15d5 | 1 | 2019-09-05 |
| 0641-6188-10 | ML - Milliliter | 0641-6188 | dc2725e9-f36f-4048-8606-000855e71be6 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
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 Hypertonicity | SODIUM CHLORIDE | CVS PHARMACY | d5cc6cd1-ddf8-4f5b-a021-204cdda0db94 | 2026-01-15 | Warnings | 451W47IQ8X |
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | 04JA59TNSJ |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | 04JA59TNSJ |
| Foster and Thrive Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | 3429aedc-e83d-498a-bfca-03aaf5847b3b | 2026-01-15 | Warnings | 04JA59TNSJ |
| ACTINEL DM Pediatric | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 2026-01-15 | Warnings | 04JA59TNSJ |
| Walgreens Sterile Soothing Eye Wash | PURIFIED WATER | Walgreens | a62e3294-abd6-48dc-81b1-62a809bdc968 | 2026-01-14 | Warnings | 059QF0KO0R |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | 2dd710ac-ab04-4a24-826f-b5a44d058168 | 2026-01-14 | Warnings | 04JA59TNSJ |
| Walgreens Hemorrhoidal | HEMORRHOIDAL RECTAL SUPPOSITORIES | Walgreens | ca98dea5-767d-49a8-887b-d96cad487fc4 | 2026-01-14 | Warnings | 04JA59TNSJ |
| GNP Hemorrhoidal Maximum Strength | HEMORRHOIDAL | Amerisourcebergen Drug Corporation | 24103355-cd72-55b0-e063-6394a90a90ec | 2026-01-14 | Warnings | 04JA59TNSJ |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | 04JA59TNSJ |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | 04JA59TNSJ |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | 04JA59TNSJ |
| Constipation Relief | ALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDE | Homeocare Laboratories | 62374240-cd14-44e2-9405-5f8996faf047 | 2026-01-12 | Warnings | 451W47IQ8X |
| Luffa | LUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTA | Marco Pharma International LLC. | 7dbb79de-c3f5-4245-884a-a6bd29bb861c | 2026-01-12 | Warnings | 451W47IQ8X |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | 04JA59TNSJ |
| Suphedrine PE Sinus Congestion Non-Drowsy | PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | b9122fd0-0bed-4302-9bbe-cd6a46d29818 | 2026-01-12 | Warnings | 04JA59TNSJ |
| Sinu-Phen Plus Sinus Pain and Pressure | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Wildman Business Group | c66e0b52-5531-4a84-ae90-8a26d27df1ec | 2026-01-12 | Warnings | 04JA59TNSJ |
| SU PHEDRINE PE SINUS CONGESTION | PHENYLEPHRINE HCL | Salado Sales, Inc. | ba075ff7-4e26-4856-8335-0c7dd4e198ea | 2026-01-12 | Warnings | 04JA59TNSJ |
| Nasal Decongestant PE Non-Drowsy Maximum Strength | PHENYLEPHRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d | 2026-01-12 | Warnings | 04JA59TNSJ |
| Hepaticol Drops 5008 | HEPATICOL DROPS | Professional Complementary Health Formulas | 79ee9e37-7853-4560-a87d-cdaefb603bbb | 2026-01-08 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.