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 |
|---|---|---|---|---|---|---|
| MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5a397466-8721-4060-a178-5ebfd7069cc9 | 2026-05-13 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Cepacol Extra Strength Sore Throat and Cough | BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c0cc32db-90f0-4106-8538-89821083ece1 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9467ca2-df75-4fa1-92b3-d2101eb54a77 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Mucinex Nightshift Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 12420092-3ef6-464b-9106-2d56cd6ef200 | 2026-05-13 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 09fdf96f-345f-43f2-9f0f-8303ac70849e | 2026-05-13 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Mucinex Childrens Mighty Chews Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 51bb483f-3fe6-8a94-e063-6394a90acf7d | 2026-05-13 | Warnings, Adverse reactions | TC2D6JAD40 |
| Acetaminophen | ACETAMINOPHEN | Acetris Pharma Holdings, LLC | dacbe2eb-f412-4629-a8ff-237c7fd10ab6 | 2026-05-13 | Warnings | 362O9ITL9D |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Walgreen Company | ec3618dd-8713-4f3c-b639-fc240021c7be | 2026-05-13 | Warnings | TC2D6JAD40 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 2ac53cc7-000f-41fd-b799-4e6d6886fe62 | 2026-05-13 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Sleep Aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | fbedb50d-b96f-4ce4-a1dc-d2b357cf6de1 | 2026-05-13 | Warnings | TC2D6JAD40 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 2201d5c0-bd51-47a7-9775-916b18573623 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | 8ebd9949-ef53-4d66-a20c-3e0047b3e1ef | 2026-05-13 | Warnings | TC2D6JAD40 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Chain Drug Marketing Association, Inc. | 17216bf3-bed0-4d7a-994e-76a0e4c79c5c | 2026-05-13 | Warnings | 362O9ITL9D |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | f868e4a0-e9fb-4e6a-9984-29a218246241 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 2026-05-13 | Warnings | M012 362O9ITL9D |
| Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZ | ETHYL ALCOHOL | Ashtel Studios Inc. | 80e475a5-97d7-4ad9-9be1-0ccdb42e6fce | 2026-05-12 | Warnings | 3K9958V90M |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1 | 2026-05-12 | Warnings | 6DC9Q167V3 |
| SudoGest | PSEUDOEPHEDRINE HYDROCHLORIDE | Major Pharmaceuticals | 78faa497-6743-b85b-e053-2a91aa0ae822 | 2026-05-12 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.