nitetime cold and flu
- Product NDC
- 41250-335
- 11-digit product format
- 412500335
- Labeler code
- 41250
- Product ID
- 41250-335_d30b1a85-a76e-486c-b145-cac3cda64450
- 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
- 2011-09-21
- 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
- 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 | 41250-335 | 41250-335-38 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 41250-335 | 41250-335-43 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-335-43 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41250-335-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-335-43 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41250-335-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-335-43 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41250-335-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-335-43 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41250-335-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-335-43 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41250-335-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-335-43 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41250-335-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-335-43 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41250-335-38 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-335-43 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41250-335-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-335-43 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41250-335-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-335-43 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41250-335-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-335-43 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41250-335-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41250-335-43 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41250-335-38 | 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 | 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 |
|---|---|
| dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-335-38 | nitetime cold and flu | 296 mL in 1 BOTTLE | SOLUTION | 296 | 9 | |
| 41250-335-40 | nitetime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 9 | |
| 41250-335-43 | nitetime cold and flu | 473 mL in 1 BOTTLE | SOLUTION | 473 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41250-335 | NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20241218_dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b.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 |
|---|---|---|---|---|---|---|
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | f1a4ee57-33a3-4791-a769-b208b38acb72 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY Childrens Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | c499574c-f32b-4608-bf8b-51ad44e35725 | 2026-07-13 | Warnings | M012 |
| Good NeighborChildrens Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | f442c61b-7d2c-401c-b862-acbe2282927b | 2026-07-13 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 5683b099-f029-2d08-e063-6394a90ad482 | 2026-07-13 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f673cdeb-4f8b-46b4-be92-c725d74abc55 | 2026-07-13 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | e4fca5ba-2d45-4c38-b0fd-297159d1705a | 2026-07-13 | Warnings | M012 |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | AMERISOURCE BERGEN | 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 | 2026-07-13 | Warnings | M012 |
| Propolis Cooling Relief Cherry Cough Drops | MENTHOL, UNSPECIFIED FORM | Beekeeper's Naturals USA Inc | 7087566d-f24a-4508-aa25-7f42d055c43e | 2026-07-13 | Warnings | M012 |
| Sinus Pressure and Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Rite Aid Corporation | 35bcf263-3296-4d9c-84c0-146a173d6e87 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Childrens Cough Relief Cherry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | a8e2fd43-b801-41ae-8d79-8ecf4a771543 | 2026-07-13 | Warnings | M012 |
| Good Neighbor No Drip Nasal Mist Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | 7872aadd-b23c-431f-8048-24eece25ca2d | 2026-07-13 | Warnings | M012 |
| Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | 404a3521-8340-4476-a068-0e69cd0e514f | 2026-07-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Long Acting Cough Adult Tussin | DEXTROMETHORPHAN HBR | AMERISOURCE BERGEN | df3c76bd-bd5b-42d7-a5f1-560fd3cba646 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Adult Tussin Mucus and chest congestion | GUAIFENESIN | AMERISOURCE BERGEN | 97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | a217ca8a-1c00-4816-bc26-cc0f71c80c90 | 2026-07-13 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 2026-07-10 | Warnings | M012 |
| COUGH DROPS- menthol granule | MENTHOL GRANULE | Anhui Jiuhe Health Industry Co., Ltd | 5351b943-5830-e4e7-e063-6394a90a5b66 | 2026-07-10 | Warnings | M012 |
| ValuMeds Nasal Decongestant PE Phenylephrine | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 3f284420-87c1-4c17-99e5-bc569bf9d45f | 2026-07-10 | Warnings | M012 |
| Severe Congestion and Cough Multi-Symptom Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 2026-07-10 | 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 | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 9 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 9 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 9 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 9 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-335-38 | 41250033538 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 41250-335-40 | 41250033540 | 355 mL in 1 BOTTLE (41250-335-40) | 355 ml | 2012-10-24 | 0000-00-00 | No | No | Current |
| 41250-335-43 | 41250033543 | 473 mL in 1 BOTTLE | 473 ml | Historical |