NDC 68083-338-01 - 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
- 68083-338
- Requested NDC
- 68083-338-01
- Package NDCs from labels
- 68083-338-01, 68083-338-10
- 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 |
|---|---|---|---|---|---|---|
| 68083-338-01 | phenylephrine hydrochloride | 5 mL in 1 VIAL | INJECTION | 5 | 8 | |
| 68083-338-10 | phenylephrine hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68083-338 | 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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY, INC | bbb1b395-48d9-4859-ad52-6650961089d9 | 2025-12-01 | Warnings | 04JA59TNSJ |
| Severe Sinus Pain and Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fbc541ac-9465-4296-bb1e-811b9d811f40 | 2025-11-26 | Warnings | 04JA59TNSJ |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | WALGREENS CO. | bfc58cd5-9815-43af-895d-ec6cbd10937e | 2025-11-26 | Warnings | 04JA59TNSJ |
| Walgreens | CHILDRENS STUFFY NOSE AND COLD | WALGREENS CO. | 7ac3de2d-1d10-49ec-a2da-da46977684ad | 2025-11-26 | Warnings | 04JA59TNSJ |
| Walgreen Saline | NASAL | WALGREENS CO. | ee264d8b-0bb2-472a-907c-6a6291f154cd | 2025-11-26 | Warnings | 451W47IQ8X |
| Walgreen Daytimel Kids Cold Cough plus Mucus | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 452159e0-1204-460c-981f-cace4e815c6f | 2025-11-26 | Warnings | 04JA59TNSJ |
| Dr Butlers Hemorrhoid and Fissure PF | LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25 | Beyond Health P.A. | f526199e-5c9e-7a3c-e053-2a95a90aa98e | 2025-11-26 | Warnings | 04JA59TNSJ |
| Aquanaz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Capital Pharmaceutical, LLC | 5e9e4dfd-4def-4756-9bba-d25068640101 | 2025-11-26 | Warnings | 04JA59TNSJ |
| Nighttime Wal Flu Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WALGREEN CO. | e88f7777-9987-4e3c-a3d5-3da60f190bfd | 2025-11-25 | Warnings | 04JA59TNSJ |
| Multi Symptom Wal Flu Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WALGREEN CO. | 9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb | 2025-11-25 | Warnings | 04JA59TNSJ |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.