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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| Rite Aid Itch Relief | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Rite Aid | e285df43-317c-d862-e053-2a95a90acdce | 2026-04-23 | Warnings | TC2D6JAD40 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 362O9ITL9D |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 48912649-9fa1-a11f-e063-6294a90a8a72 | 2026-04-23 | Warnings | 362O9ITL9D |
| SOUR LEMON HAND SANITIZER Island Coco Scent | ETHYL ALCOHOL | Diamond Life Cosmetics Trading FZCO | 9e4d9add-0a02-4cce-91e0-7c3ce3ad5cb2 | 2026-04-23 | Warnings | 3K9958V90M |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 TC2D6JAD40 |
| SOUR LEMON HAND SANITIZER Sugar Lemon Scent | ETHYL ALCOHOL | Diamond Life Cosmetics Trading FZCO | baa5166d-e41f-46aa-adae-038f444bb54e | 2026-04-23 | Warnings | 3K9958V90M |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a70867e-481d-4f01-9da3-d85663a1672e | 2026-04-23 | Warnings | 362O9ITL9D |
| FRESH FEELS HAND SANITIZER MIST LAVENDER SCENT | ETHYL ALCOHOL | Amber Glow Cosmetics Limited | 8efafedf-a66e-44a3-b2af-700292f1d001 | 2026-04-23 | Warnings | 3K9958V90M |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | ee50c5ee-1a61-4efc-aca9-42d897d6a3b8 | 2026-04-22 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 69ce724d-6440-4def-aea9-26ad284ac35c | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 639aba0b-1ef6-415f-9732-ebf52bcc1b86 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISER | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 5006097e-16e6-d180-e063-6394a90ae0c2 | 2026-04-22 | Warnings | 3K9958V90M |
| BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM | HAIR GROWTH SERUM | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 409de2af-f6f6-8181-e063-6294a90a0b4b | 2026-04-22 | Warnings | 3K9958V90M |
| BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM | MINOXIDIL | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 5009b231-23c3-7356-e063-6394a90a569f | 2026-04-22 | Warnings | 3K9958V90M |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.