NDC 68083-465-01 - 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
- 68083-465
- Requested NDC
- 68083-465-01
- Package NDCs from labels
- 68083-465-01, 68083-465-25
- Manufacturer
- Gland Pharma Limited
- Effective date
- 2021-04-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| phenylephrine hydrochloride - Gland Pharma Limited | Gland Pharma Limited | 2021-04-14 | Human Prescription Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68083-465-01 | Phenylephrine HydrochloridePhenylephrine Hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | 8 | |
| 68083-465-25 | Phenylephrine HydrochloridePhenylephrine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68083-465 | PHENYLEPHRINE HYDROCHLORIDE INJECTION PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [GLAND PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20210415_6486d284-5189-4000-aa7d-67150e84a7b2.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 |
|---|---|---|---|---|---|---|
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | 04JA59TNSJ |
| day time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | eaf3af6a-de5b-43fe-83ff-9641646e0f6b | 2025-11-25 | Warnings | 04JA59TNSJ |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | beda35c3-9a8b-47ad-e053-2995a90a7b1b | 2025-11-24 | Warnings | 059QF0KO0R |
| Easy Care First Aid Eyewash | WATER | Tender Corporation | a070aac8-e6d2-ef10-e053-2a95a90aa5b1 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | e07a064b-f680-405c-bbcd-24fac430951e | 2025-11-24 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Niagara Pharmaceuticals Inc. | 2d7f22d2-320b-6af1-e063-6294a90addc6 | 2025-11-24 | Warnings | 059QF0KO0R |
| Pur-Wash | EYEWASH | Niagara Pharmaceuticals, Inc. | 0d43b1c1-2699-37f1-e054-00144ff88e88 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 777e1559-786f-8d54-e053-2991aa0aa98d | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| Natural Eyes Floaters Relief | CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA | TRP Company | 445dc831-195e-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings | 451W47IQ8X |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | e19b561c-fb76-4355-a306-d3dc46930bf2 | 2025-11-24 | Warnings | 04JA59TNSJ |
| Phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Provepharm Inc. | e1d3881f-fa9e-4d68-8ef0-9e03435fc292 | 2025-11-24 | Warnings, Adverse reactions | 1232651 1666372 04JA59TNSJ |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Cardinal Health (Leader) 70000 | 14c507df-fbac-4a09-a66c-b91c2abbf550 | 2025-11-24 | Warnings | 04JA59TNSJ |
| Severe Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI | Family Dollar (FAMILY WELLNESS) | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 2025-11-24 | Warnings | 04JA59TNSJ |
| Childrens Multi-symptom Cold Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | 1768677d-96ec-f9f7-e063-6394a90a4ef4 | 2025-11-21 | Warnings | 04JA59TNSJ |
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Vital Female Sexual Energy | AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 1ca43c82-62b0-4191-81a4-27f7f94109dd | 2025-11-20 | Warnings | 451W47IQ8X |
| Supress DX Pediatric Drops | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | ddb95436-7806-4086-af4d-18a6625b5c83 | 2025-11-20 | Warnings | 04JA59TNSJ |
| Sodium Chloride | SODIUM CHLORIDE | Walgreen Company | d112a344-33cc-41d3-bae6-492631ebdba7 | 2025-11-19 | Warnings | 451W47IQ8X |
| Hemorrhoidal Cream | GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM | Trifecta Pharmaceuticals Usa Llc | 804d7b1f-1be8-50c9-e053-2a91aa0a35d0 | 2025-11-18 | Warnings | 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.