NITETIME COLD AND FLU
- Product NDC
- 79481-8301
- 11-digit product format
- 794818301
- Labeler code
- 79481
- Product ID
- 79481-8301_a2ab4e51-cdc7-4bf8-a1b9-f7100e7c0437
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Meijer, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 10; 6.25 mg/15mL; mg/15mL; mg/15mL
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITETIME COLD AND FLU
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| DOXYLAMINE SUCCINATE | 6.25 mg/15mL |
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 |
|---|---|
| 1042675 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0e65c5d1-a18b-452c-9be6-8d44d34577e9 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Honey Lemon | MENTHOL | Riclan S.A. | f6271e85-9ca2-41d3-9bff-a13670ac5b80 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Strawberry | MENTHOL | Riclan S.A. | da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 | 2023-10-26 | Warnings | M012 |
| DG Health Cough Drops Assorted Flavors | MENTHOL | Dollar General Corporation | c731d255-40f2-3cb3-e053-2a95a90a8877 | 2023-10-26 | Warnings | M012 |
| ALKA SELTZER PLUS Cold Day and Night Effervescent | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Sincronia Logistica, S.A. de C.V. | c478df69-823a-4112-8f44-323249a9f38f | 2023-10-23 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 169006cb-7dc2-4113-a289-0b1f14e784b7 | 2023-10-23 | Warnings | M012 |
| Night-Time Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | HealthLife of USA | 2ffd62a6-703f-4cb0-bb13-49719c004d00 | 2023-10-21 | Warnings | M012 |
| Day-Time Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN | HealthLife of USA | c5f6cf22-2aaa-40e1-b7b3-448e55898d62 | 2023-10-21 | Warnings | M012 |
| PENTREXCILINA | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Healthlife of USA | ae9ada14-0ec8-4c01-a874-237f2108936a | 2023-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | APNAR PHARMA LP | e5004c10-3877-c199-e053-2a95a90aa8ac | 2023-10-21 | Boxed warning, Warnings | M012 |
| Day and Night Multi Symptom Cold and Flu Relief | DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF | Intrivo Diagnostics Inc. | a311bf39-de6c-4ed5-949e-718ad8be1e49 | 2023-10-13 | Warnings | M012 |
| Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 2023-10-10 | Warnings | M012 |
| Triacting Daytime Cold Cough Childrens | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8656aa2e-9546-4de4-9ecc-ce99bf903333 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | a33ae35b-1cde-4a3d-a836-3b169e4f1bb9 | 2023-10-10 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 553d01a9-e8ad-4797-b55b-32f134f08af9 | 2023-10-10 | Warnings | M012 |
| Mucus Relief Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 8781e2c5-ad46-4615-a0d9-879590e86f95 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 419df833-1f33-45cf-bab3-730c928d5887 | 2023-10-10 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 93a5cb36-3262-4224-a5be-5ea1619a67bd | 2023-10-10 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | CVS Pharmacy | 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6 | 2023-10-09 | Warnings | M012 |
| Cold and Congestion Childrens Nighttime | DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL | Walgreens | a7847413-e556-4f88-8a7f-a8528afbe927 | 2023-10-09 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | 06d2c6cf-0adb-91b9-e063-6294a90aff52 | 2023-10-03 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 79481-8301-4 | 79481830104 | 355 mL in 1 BOTTLE (79481-8301-4) | 355 ml | 2026-07-01 | No | No | Current |