NDC 69097-534-31 - 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
- 69097-534
- Requested NDC
- 69097-534-31
- Package NDCs from labels
- 69097-534-31, 69097-534-97
- Manufacturer
- Cipla USA Inc. | Cipla Ltd.- Goa | Malladi Drugs and Pharmaceuticals Limited
- Effective date
- 2020-07-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PHENYLEPHRINE - Cipla USA Inc. | Cipla Ltd.- Goa | Malladi Drugs and Pharmaceuticals Limited | Cipla USA Inc. | Cipla Ltd.- Goa | Malladi Drugs and Pharmaceuticals Limited | 2020-07-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-534-31 | ML - Milliliter | 69097-534 | c4ae8cf4-248d-4dbf-bef9-3e91a4a11bc1 | 1 | 2018-06-11 |
| 69097-534-97 | ML - Milliliter | 69097-534 | aa2dc95a-8226-4e4b-b760-f0d08b0d74c5 | 1 | 2018-06-11 |
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 |
|---|---|---|---|---|---|---|
| HyVee Daytime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 496ec389-1aea-f202-e063-6394a90ae51c | 2026-08-20 | Warnings | 04JA59TNSJ |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | 451W47IQ8X |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | 04JA59TNSJ |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 2517b241-c433-440f-999d-5a32d5bbaa26 | 2026-08-19 | Warnings | 04JA59TNSJ |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 2026-08-19 | Warnings, Adverse reactions | 04JA59TNSJ |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY | e1c246a4-7a8c-4761-ab26-13b5165029cc | 2026-08-19 | Warnings | 04JA59TNSJ |
| CVS Childrens Nighttime Multi Symptom Cold | ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 9b244ac8-4ca7-43a0-b328-88f15f0fcc9d | 2026-08-19 | Warnings | 04JA59TNSJ |
| CVS | CHILDRENS STUFFY NOSE AND COLD | CVS PHARMACY, INC | 6cff265d-94a3-4617-a366-fe970d97f05a | 2026-08-19 | Warnings | 04JA59TNSJ |
| CVS Severe Congestion and Pain Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS | 5a8e4320-bae1-4831-b66b-9babfe8888d6 | 2026-08-19 | Warnings | 04JA59TNSJ |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | 04JA59TNSJ |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | df18a603-ca12-4b26-83b5-9dd07b6453ab | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | 04JA59TNSJ |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | 04JA59TNSJ |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | 04JA59TNSJ |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | 04JA59TNSJ |
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | 04JA59TNSJ |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.