NDC 49580-0502-08 - Nighttime Severe Cold and Cough
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
- 49580-0502
- Requested NDC
- 49580-0502-08
- Package NDCs from labels
- 49580-0502-8, 49580-0502-08
- Manufacturer
- P & L Development, LLC
- Effective date
- 2024-04-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nighttime Severe Cold and Cough - P & L Development, LLC | P & L Development, LLC | 2024-04-15 | HUMAN OTC DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0502-8 | 2023-05-17 | C162847 | 48780-1 | f386c649-e055-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0502-8 | 2023-01-30 | C162847 | 48780-1 | f386c649-e055-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0502-8 | Nighttime Severe Cold and Cough | 245 mL in 1 BOTTLE, PLASTIC | LIQUID | 245 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0502 | NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240417_8d27b94d-23a1-4e6c-a064-79e2580f7e2e.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 |
|---|---|---|---|---|---|---|
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | ARMY AND AIR FORCE EXCHANGE SERVICE | ff39084f-ab2f-48ed-ac62-837f7fff2b65 | 2026-05-28 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group LLC | 52c5fda0-c358-72e8-e063-6394a90a3f68 | 2026-05-27 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| TYLENOL Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1622f694-4d63-4c56-8737-fae31f0ecfb7 | 2026-05-27 | Warnings | 362O9ITL9D |
| myDerm MEDICAL NEW Soothing Hemorrhoidal | WITCH HAZEL PENYLEPHRINE LIDOCAINE | Inspec Solutions | 2ff42501-7730-42de-99dd-6fc53bbdf25f | 2026-05-27 | Warnings | 04JA59TNSJ |
| Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 16637d54-8049-d3ce-e063-6394a90aafc9 | 2026-05-27 | Warnings | M012 |
| PURELL Advanced Hand Sanitizer E3 Gel | ALCOHOL | GOJO Industries, LLC | 52d04540-b14b-8c88-e063-6394a90afd39 | 2026-05-27 | Warnings | 3K9958V90M |
| Childrens Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 2026-05-27 | Warnings | M012 04JA59TNSJ TC2D6JAD40 362O9ITL9D |
| Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 9aca1a68-893c-4770-8a48-d5d678058253 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | d26b5143-aa07-4114-a6ba-4f503aadd46f | 2026-05-27 | Warnings | M012 |
| Goodmeds Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 37533188-8c91-428b-a796-c5afd9e4959f | 2026-05-27 | Warnings | M012 TC2D6JAD40 |
| Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 8252cdec-b668-4450-b045-e093479ab542 | 2026-05-27 | Warnings | M012 |
| Delsym Nighttime Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27f9d2db-38ce-41d2-8f1a-0eb171600274 | 2026-05-27 | Warnings | M012 362O9ITL9D |
| Delsym Cough Plus Sore Throat | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | b37b786e-0cce-419d-94ed-3b64a1eb1201 | 2026-05-27 | Warnings | M012 362O9ITL9D |
| Delsym Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | a43d59f9-3a6c-4a7c-b98d-b86d6035f716 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Relief Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 5700ef26-ffa6-480a-bf36-bd5111799e9b | 2026-05-27 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| INFANTS Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | 257436e1-e0f3-4a87-bffe-4f176b836caf | 2026-05-27 | Warnings | 362O9ITL9D |
| Air Power | GUAIFENESIN | Schwabe North America, Inc | 5cdefc7a-6242-4681-88a3-04422a1d48d3 | 2026-05-27 | Warnings | M012 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 44687e20-a1c4-4cf3-b2ac-4d489d54b740 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | adb658c8-db8d-4db6-80c8-e0f2de88a2de | 2026-05-27 | Warnings | M012 362O9ITL9D |
| migraine relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Rite Aid Corporation | 80e58390-69fb-48f7-ad3a-a13f125cd921 | 2026-05-27 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.