nitetime cold and flu
- Product NDC
- 41250-459
- 11-digit product format
- 412500459
- Labeler code
- 41250
- Product ID
- 41250-459_ec3f31a0-24ba-44e8-9138-1fbee7f7bf5c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Meijer Distribution Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-09-09
- 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
- Listing certified through
- 2027-12-31
- 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 | 41250-459 | 41250-459-38 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 41250-459 | 41250-459-43 | D | Discontinued by firm | 2026-10-21 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-459-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-459-43 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-459-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-459-43 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-459-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-459-43 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-459-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-459-43 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-459-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-459-43 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-459-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-459-43 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-459-38 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-459-43 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-459-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-459-43 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-459-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-459-43 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-459-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-459-43 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-459-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-459-43 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41250-459-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41250-459-43 | 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
- 2027-12-31
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 |
|---|---|
| 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-459-38 | nitetime cold and flu | 296 mL in 1 BOTTLE | SOLUTION | 296 | 10 | |
| 41250-459-40 | nitetime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 41250-459-43 | nitetime cold and flu | 473 mL in 1 BOTTLE | SOLUTION | 473 | 10 | |
| 41250-459-40 | daytime nitetime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41250-459 | NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240927_582fa36b-6d0c-4ff3-80ab-6e0da4b209e4.zip |
| 41250-459 | DAYTIME NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER, INC.] | 7 | Current NDC, Legacy NDC | 20241205_80aae1c3-a616-442b-842e-177db957a69c.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 |
|---|---|---|---|---|---|---|
| NASAL and SINUS DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | JHK Inc dba American Safety & First Aid | 63e51305-2575-49c4-9fda-7b3e1b4b6ede | 2024-04-26 | Warnings | M012 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Haleon US Holdings LLC | 7decc168-e847-4bbe-910b-26081469406f | 2024-04-26 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 7c92bdcf-db1f-4299-982f-6a3da9cba6e6 | 2024-04-25 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 15727e06-7bfc-424e-9e68-cc9cd5695bfd | 2024-04-25 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 5872fed8-862b-44a2-a06e-51ebf8618271 | 2024-04-25 | Warnings | M012 |
| CHERRY COUGH DROPS 50CT | MENTHOL, UNSPECIFIED FORM | JHK Inc dba American Safety & First Aid | 2f54b9c1-3a37-48fd-b964-6aa2631b8e62 | 2024-04-24 | Warnings | M012 |
| Dye Free Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | f1a33c2f-2330-43f3-8026-de21808aec66 | 2024-04-22 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | fc7954a6-d061-4160-b1d1-a19eb9eabff4 | 2024-04-22 | Warnings | M012 |
| Dibromm Cold and Allergy Childrens | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 2024-04-22 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c573da1e-c7ca-46e6-ad42-4ded2547afc3 | 2024-04-22 | Warnings | M012 |
| Cough Relief Cough Suppressant | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 13ae4c67-a3fe-440c-91b8-c9412626c3cd | 2024-04-22 | Warnings | M012 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 47660794-22cc-4863-a183-e694d27e3543 | 2024-04-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9c08b18-a119-406b-bd96-73572b4445e2 | 2024-04-18 | Warnings | M012 |
| Nighttime Cough Relief | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | e1fa0f51-6a68-4f6f-8988-0949d1942c2f | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 025f6622-a6db-4a5c-aebd-5d54172fa4a1 | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9530d55-8226-4659-84f0-2c0b411572be | 2024-04-17 | Warnings | M012 |
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | M012 |
| MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG | RITE AID | c9323799-3505-d6c1-e053-2995a90a6f43 | 2024-04-17 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fac8b01a-9666-43cc-a4ff-3f3ed452c7e4 | 2024-04-17 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | P & L Development, LLC | 15e9a336-1b34-4f00-9d1c-b945ddf17ed9 | 2024-04-16 | 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 | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 10 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 10 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 10 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 10 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 10 |
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 80aae1c3-a616-442b-842e-177db957a69c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-459-38 | 41250045938 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 41250-459-40 | 41250045940 | 355 mL in 1 BOTTLE (41250-459-40) | 355 ml | 2012-10-29 | 0000-00-00 | No | No | Current |
| 41250-459-43 | 41250045943 | 473 mL in 1 BOTTLE (41250-459-43) | 473 ml | 2011-09-09 | 0000-00-00 | No | No | Current |