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 |
|---|---|---|---|---|---|---|
| nasal decongestant maximum strength non drowsy | PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 8a68ca99-fd76-409a-9769-88830e8720a8 | 2024-09-28 | Warnings | M012 |
| good neighbor pharmacy tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | 58687394-b6d2-4d51-bde0-8f2cfa3fe909 | 2024-09-27 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Amerisource Bergen | faee3aae-e819-4084-a127-3449be353b13 | 2024-09-27 | Warnings | M012 |
| Tesalon Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL | OPMX LLC | 2309620a-ccbc-41e9-e063-6394a90a9520 | 2024-09-26 | Warnings | M012 |
| adult cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Meijer, Inc. | b11c4cee-bbb5-4585-9d38-6787553e13a0 | 2024-09-26 | Warnings | M012 |
| COLD AND FLU NIGHTTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3 | 2024-09-25 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8f3317f6-4ae8-474b-93c3-25e256519cb8 | 2024-09-25 | Warnings | M012 |
| berkley and jensen tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | b2de91c9-6af0-4881-8d2d-a69d90c8dfcd | 2024-09-24 | Warnings | M012 |
| Tussin DM Cough and Chest Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 13eb459c-3075-4038-8062-9ee7175b2ab9 | 2024-09-24 | Warnings | M012 |
| equaline nasal decongestant non drowsy maximum strength | PSEUDOEPHEDRINE HCL | United Natural Foods, Inc. dba UNFI | 8897580a-709a-4643-8264-ad003d90cbff | 2024-09-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M012 |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | CVS Pharmacy | bebe5e78-09ba-4d35-9d34-9f5e34341478 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | 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 |