Night Time Cold and Flu
- Product NDC
- 49580-0343
- 11-digit product format
- 495800343
- Labeler code
- 49580
- Product ID
- 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-31
- Marketing end
- 2026-12-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 49580-0343-8 |
| excluded package | package | 49580-0343-4 |
| excluded package | package | 49580-0343-6 |
| excluded package | package | 49580-0343-2 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Night Time Cold and Flu
- Brand name suffix
- ReadyInCase
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e7dd763b-3005-4723-933b-171eb772afee | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 49580-0343-2 | 2023-05-24 | Drug Facts |
| 49580-0343-4 | 2023-05-24 | Drug Facts |
| 49580-0343-6 | 2023-05-24 | Drug Facts |
| 49580-0343-8 | 2023-05-24 | Drug Facts |
| 49580-0343-2 | 2023-01-30 | Drug Facts |
| 49580-0343-4 | 2023-01-30 | Drug Facts |
| 49580-0343-6 | 2023-01-30 | Drug Facts |
| 49580-0343-8 | 2023-01-30 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0343-2 | Night Time Cold and FluReadyInCase | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 13 | |
| 49580-0343-4 | Night Time Cold and FluReadyInCase | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 13 | |
| 49580-0343-6 | Night Time Cold and FluReadyInCase | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 13 | |
| 49580-0343-8 | Night Time Cold and FluReadyInCase | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0343 | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241211_e7dd763b-3005-4723-933b-171eb772afee.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 | Geiss, Destin & Dunn Inc. | 1ea07a01-8779-48c2-a287-b7be866cce7b | 2026-09-10 | Warnings | M012 |
| Childrens Cold and Allergy Relief | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | d64fe757-9948-4727-b5dd-1f8e4e4763e2 | 2026-09-10 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | M012 |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | M012 |
| 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 |
| 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 |
| DRx Choice Long Acting Cough | DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | 875b40bd-7955-4048-abbf-7f43d9ea3ac5 | 2026-09-09 | Warnings | M012 |
| 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 |
| 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 |
| Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | The Kroger Co. | 49829083-5c0a-4620-bfb3-7103642368db | 2026-09-09 | Warnings | M012 |
| DRx Choice Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS | 7a3bb739-ff50-4d29-b270-d6b084906493 | 2026-09-09 | Warnings | M012 |
| DRx Choice Children daytime Cough and Chest Congestion | DEXTROMETHORPHAN HBR AND GUAIFENESIN | RARITAN PHARMACEUTICALS | 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 8a166067-b492-4742-b74c-28fac87c8d70 | 2026-09-09 | Warnings | M012 |
| DRx Choice maximum strength Severe Cough plus sore throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | a096cb76-0d1c-4ca8-854a-5199da0bc8f7 | 2026-09-09 | Warnings | M012 |
| Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb69cc1-a745-6efc-e053-2a95a90abdc9 | 2026-09-08 | Warnings | M012 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efb5f0b9-9825-ab23-e053-2995a90a26ab | 2026-09-08 | Warnings | M012 |
| Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | f4328b44-cdfa-41aa-e053-2995a90a2728 | 2026-09-08 | Warnings | M012 |
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2026-09-08 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | e7dd763b-3005-4723-933b-171eb772afee | 13 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | e7dd763b-3005-4723-933b-171eb772afee | 13 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | e7dd763b-3005-4723-933b-171eb772afee | 13 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | e7dd763b-3005-4723-933b-171eb772afee | 13 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | e7dd763b-3005-4723-933b-171eb772afee | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49580-0343-2 | 49580034302 | 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2) | 355 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-4 | 49580034304 | 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4) | 118 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-6 | 49580034306 | 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6) | 177 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-8 | 49580034308 | 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8) | 237 ml | 2014-10-31 | 2026-12-31 | No | No | Current |