NiteTime Cold and Flu
- Product NDC
- 49035-044
- 11-digit product format
- 490350044
- Labeler code
- 49035
- Product ID
- 49035-044_742f2d49-197c-49bd-9675-d503b77811c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-12-31
- Marketing end
- 2027-07-28
- 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
- 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
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-044-12 | NiteTime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 7 | |
| 49035-044-24 | NiteTime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 7 | |
| 49035-044-24 | NiteTime Cold and Flu | 2 in 1 PACKAGE | LIQUID | 2 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-044 | NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241009_7b3c4793-9369-4331-bd5a-40f20b9df2b0.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 |
|---|---|---|---|---|---|---|
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| good sense allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | 2cfa69b4-e33f-442a-a6df-b021b041da14 | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | 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 | 7b3c4793-9369-4331-bd5a-40f20b9df2b0 | 7 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 7b3c4793-9369-4331-bd5a-40f20b9df2b0 | 7 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 7b3c4793-9369-4331-bd5a-40f20b9df2b0 | 7 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 7b3c4793-9369-4331-bd5a-40f20b9df2b0 | 7 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 7b3c4793-9369-4331-bd5a-40f20b9df2b0 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-044-12 | 49035004412 | 355 mL in 1 BOTTLE, PLASTIC (49035-044-12) | 355 ml | 2014-12-31 | 2027-07-28 | No | No | Current |
| 49035-044-24 | 49035004424 | 2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24) / 355 mL in 1 BOTTLE, PLASTIC | 2014-12-31 | 2027-07-28 | No | No | Current |