NDC 49580-0416-08 - Severe cold and flu Nighttime
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
- 49580-0416
- Requested NDC
- 49580-0416-08
- Package NDCs from labels
- 49580-0416-8, 49580-0416-08
- Manufacturer
- P & L Development, LLC
- Effective date
- 2024-04-25
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Severe cold and flu Nighttime - P & L Development, LLC | P & L Development, LLC | 2024-04-25 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0416-8 | Severe cold and fluNighttime | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0416 | SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240426_7c92bdcf-db1f-4299-982f-6a3da9cba6e6.zip |
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 |
|---|---|---|---|---|---|---|
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 1022767d-a456-4fbc-95cf-91337c74c330 | 2026-10-01 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Lymph Tonic II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 0e3265b0-b210-4a4c-80d2-8a9712981d4e | 2026-09-17 | Warnings | 451W47IQ8X |
| 12 hr relief cough dm | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 03c44e2f-d6e3-4c78-9c9a-92d1708a62fe | 2026-09-16 | Warnings | 9D2RTI9KYH |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Geiss, Destin & Dunn Inc. | 1ea07a01-8779-48c2-a287-b7be866cce7b | 2026-09-10 | Warnings | M012 9D2RTI9KYH |
| Childrens Cold and Allergy Relief | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | d64fe757-9948-4727-b5dd-1f8e4e4763e2 | 2026-09-10 | Warnings | M012 04JA59TNSJ |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | M012 362O9ITL9D |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | M012 |
| childrens fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | 7f445de3-30cf-4bd8-892d-05979cd399e7 | 2026-09-09 | Warnings | 362O9ITL9D |
| dual action | ACETAMINOPHEN, IBUPROFEN | Rite Aid Corporation | 54b08d24-d5e9-4111-9d97-329896e8309d | 2026-09-09 | Warnings | 362O9ITL9D |
| DRx Choice Fruit Punch | GUAIFENESIN | Raritan Pharmaceuticals Inc | a19d7e1c-c04e-41c6-8af6-ecde96299216 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 3856c1e4-814f-85c4-e063-6394a90ab8a8 | 2026-09-09 | Warnings | M012 |
| Leader Eye Drops Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Cardinal Health | aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a | 2026-09-09 | Warnings | PDC6A3C0OX |
| DRx Choice Long Acting Cough | DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | 875b40bd-7955-4048-abbf-7f43d9ea3ac5 | 2026-09-09 | Warnings | M012 9D2RTI9KYH |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | 451W47IQ8X |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 4b8ae971-ab57-4937-a878-72d905d7b849 | 2026-09-09 | Warnings | M012 1431245 9D2RTI9KYH 04JA59TNSJ V9BI9B5YI2 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 82ba9a73-60ef-49fd-960f-5ca2bb79555e | 2026-09-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | The Kroger Co. | 49829083-5c0a-4620-bfb3-7103642368db | 2026-09-09 | Warnings | M012 9D2RTI9KYH |
| DRx Choice Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS | 7a3bb739-ff50-4d29-b270-d6b084906493 | 2026-09-09 | Warnings | M012 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.