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 | 2026-10-20 | |
| excluded package | package | 41250-459 | 41250-459-43 | D | Discontinued by firm | 2026-10-20 |
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 |
|---|---|---|---|---|---|---|
| Meclizine HCL | MECLIZINE HCL 25MG CHEWABLE TABLETS | Aphena Pharma Solutions - Tennessee, LLC | 02d1af4d-d97d-4019-a5bf-3ec391238676 | 2025-01-09 | Warnings | M012 |
| HISTEX PD Drops New Formulation | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 0c693f15-5d76-3dbf-e063-6294a90af9ac | 2025-01-08 | Warnings | M012 |
| DEXTROMETHORPHAN HBR 15 MG | DEXTROMETHORPHAN HBR 15 MG | AMZ789 LLC | e2175017-6a0d-0155-e053-2995a90a65d6 | 2025-01-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Health Pharma USA LLC | 29bb7822-76c6-e39d-e063-6294a90a64fb | 2025-01-07 | Warnings | M012 |
| Childrens Allergy Relief | CHILDRENS ALLERGY RELIEF | Allegiant Health | cb6df361-b8e5-4e2f-945f-c20159d76c4f | 2025-01-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | WinCo Foods, LLC | bb7a9fed-dc04-4c31-aa7f-4185d955242c | 2025-01-06 | Warnings | M012 |
| Leader Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | 207b2677-aaad-4fe4-a96d-963b7dcfba70 | 2025-01-06 | Warnings | M012 |
| Allergy Relief Caplet | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 126c05e7-2cd9-47d3-96c3-82305714e1db | 2025-01-02 | Warnings | M012 |
| Right Remedies Adult Long Lasting Cough Relief Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Strive Pharmaceuticals Inc. | e3ea468e-4e12-4dae-b222-8e32456b77b8 | 2025-01-02 | Warnings | M012 |
| AVON HeXashield Congestion Relief Original | OXYMETAZOLINE HYDROCHLORIDE | Tai Guk Pharm. Co., Ltd. | 8f2c152c-c564-0cba-e053-2a95a90ab3c7 | 2025-01-01 | Warnings | M012 |
| Multi-Symptom Nighttime Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Advanced Rx LLC | a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4 | 2025-01-01 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Advanced Rx LLC | 297e10e3-e740-4434-91a2-2e5c54985d33 | 2025-01-01 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Advanced Rx LLC | 64620186-a45b-4c35-a3b9-a347348f93f7 | 2025-01-01 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 57a44bbf-a304-47b9-8adc-4442c7787853 | 2025-01-01 | Warnings | M012 |
| Long Acting Cough Softgels | DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY, INC | 322daee6-c61d-43d3-a54d-a354fd3df242 | 2025-01-01 | Warnings | M012 |
| Adult Tussin DM Lil Drug Store Products | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Lil' Drug Store Products, Inc | 1915cf2a-ebaa-4c47-8991-5b741fa01be2 | 2024-12-31 | Warnings | M012 |
| Congestion Relief Lil Drug Store Products | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 8fca348c-ecb6-4a91-89dd-8bd4c05ac745 | 2024-12-31 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI SYMPTOM | DAYTIME COLD AND FLU MULTI SYMPTOM | TARGET CORP | 9dea350d-2f09-b944-e053-2995a90a2b63 | 2024-12-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb | 2024-12-30 | Warnings | M012 |
| Pediacare Childrens Cough and Cold Grape | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | fabafdc1-9dd8-4258-af49-bab1e29ad109 | 2024-12-30 | 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 |