Nitetime Cold and Flu
- Product NDC
- 41250-763
- 11-digit product format
- 412500763
- Labeler code
- 41250
- Product ID
- 41250-763_da99aac2-179f-499c-80a8-88dc141c3e46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Meijer Distribution Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-11
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 41250-763 | 41250-763-50 | D | Discontinued by firm | 2026-10-12 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-763-40 | Nitetime Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 8 | |
| 41250-763-50 | Nitetime Cold and Flu | 2 in 1 PACKAGE | SOLUTION | 2 | 8 | |
| 41250-763-50 | Nitetime Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 8 | |
| 41250-763-40 | NiteTime DayTimeCold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41250-763 | NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241016_47f03174-6e91-4529-bbfa-ce58aa7b7d79.zip |
| 41250-763 | NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] | 6 | Current NDC, Legacy NDC | 20241116_d41cb988-d39d-4f0d-bda2-633f2bad6d1f.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 |
|---|---|---|---|---|---|---|
| HyVee Daytime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 496ec389-1aea-f202-e063-6394a90ae51c | 2026-08-20 | Warnings | M012 |
| CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus chest congestion | GUAIFENESIN | CVS PHARMACY | bec04049-03b2-4465-9cf5-0ad2ef8014ef | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY, INC | fe12f3bd-3237-42d1-aec5-c831b9637175 | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | M012 |
| CVS Long Acting Cough | DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 31a7c0e2-af1c-45dd-8a93-e0879cae6005 | 2026-08-19 | Warnings | M012 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | b3baf939-a9fd-47ac-9bc7-68435e32ea1e | 2026-08-19 | Warnings | M012 |
| Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 5151127a-4d09-413a-a08b-f76fb77e1188 | 2026-08-19 | Warnings | M012 |
| CVS DT and NT Combo Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 360c8c62-0945-4031-b291-d40c4270b940 | 2026-08-19 | Warnings | M012 |
| equate childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 24758ab0-ba08-4b4a-9861-449612bdb89c | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus plus Chest Congestion | GUAIFENESIN | CVS PHARMACY | 3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cold plus Cough plus Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | CVS | 7dc30e46-e289-40fc-b217-b123fee5daee | 2026-08-19 | Warnings | M012 |
| CVS ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY | 4490a7e1-d5b9-459c-8751-c24486807981 | 2026-08-19 | Warnings | M012 |
| CVS DayTime and NightTime Value Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 4c813cd5-2c97-4fc3-926c-1a0396551a31 | 2026-08-19 | Warnings | M012 |
| CVS Adult Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS PHARMACY | 822d5bf6-8841-4b7f-bbf7-90c3d50b8024 | 2026-08-19 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 2517b241-c433-440f-999d-5a32d5bbaa26 | 2026-08-19 | Warnings | M012 |
| Daytime and Nighttime Cough and Chest Congestion Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | CVS Pharmacy | 347f1731-5b85-4220-ae2b-9497a3afa4ed | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY | e1c246a4-7a8c-4761-ab26-13b5165029cc | 2026-08-19 | Warnings | M012 |
| CVS childrens Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | CVS PHARMACY | 035c5e2a-04e3-490b-8f1a-233a5cb6eadb | 2026-08-19 | Warnings | M012 |
| rugby cough syrup | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rugby Laboratories | 89752c69-25c8-45e3-9021-f81b35b52d36 | 2026-08-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 8 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 8 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 8 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 8 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 8 |
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-763-40 | 41250076340 | 355 mL in 1 BOTTLE (41250-763-40) | 355 ml | 2013-12-11 | 0000-00-00 | No | No | Current |
| 41250-763-50 | 41250076350 | 2 BOTTLE in 1 PACKAGE (41250-763-50) > 355 mL in 1 BOTTLE | 2 bottle | 2013-12-11 | 0000-00-00 | No | No | Current |