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 |
|---|---|---|---|---|---|---|
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Cardinal Health 107, LLC | ab70f3dc-708e-4455-99ff-a2b9fe2d71a3 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 TC2D6JAD40 |
| Alcohol wet wipes | ALCOHOL WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f79dbac0-cec0-46bc-e053-6294a90a2b13 | 2026-04-25 | Warnings | 3K9958V90M |
| Wet wipes | WET WIPES | JINGXIN GROUP (M) SDN BHD | 395225b1-486b-1867-e063-6394a90a1865 | 2026-04-25 | Warnings | 3K9958V90M |
| Hand Sanitizer | ALCOHOL | MerchSource, LLC | 5054a055-50d0-f12a-e063-6294a90ad78e | 2026-04-25 | Warnings | 3K9958V90M |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| REFRESH TEARS PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Allergan, Inc. | 9e1cba7b-84ed-47f3-b19a-121992834350 | 2026-04-24 | Warnings | PDC6A3C0OX |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 TC2D6JAD40 |
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Sportpharm LLC | cc280926-ad94-4017-a04a-b4315807eacb | 2026-04-24 | Warnings | 362O9ITL9D |
| Ethyl Alcohol | ETHYL ALCOHOL | UpLift Brands, LLC | 5035ec52-2d65-cbbf-e063-6294a90a4a5c | 2026-04-24 | Warnings, Adverse reactions | 3K9958V90M |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 362O9ITL9D |
| Foaming Sanitizing Hand | ALCOHOL | Kutol Products Company | b2e22e51-88f5-4391-8705-3855c1645d80 | 2026-04-24 | Warnings | 3K9958V90M |
| B-Pure Moisturizing Hand Sanitizer Amber Breeze Scented | ALCOHOL | Fourstar Group USA, Inc. | eb39678d-7576-4147-be02-b7779a575828 | 2026-04-24 | Warnings | 3K9958V90M |
| B-Pure Moisturizing Hand Sanitizer Kick Off Scented | ALCOHOL | Fourstar Group USA, Inc. | 860f25c3-54b0-4438-ba97-0fc81cf35044 | 2026-04-24 | Warnings | 3K9958V90M |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 TC2D6JAD40 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 1c8fef8f-2ff5-4bea-bccb-90c2c8544c21 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.