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 |
|---|---|---|---|---|---|---|
| Levmetamfetamine | LEVMETAMFETAMINE | Meijer, Inc. | d11e916f-90a6-4099-bf83-75f2dfbd6266 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, DG health | LEVMETAMFETAMINE | Dolgencorp Inc. | 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3 | 2024-12-20 | Warnings | M012 |
| Tukol Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | aef2ad43-145d-4abc-bccc-2c5fdd6882f9 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health | LEVMETAMFETAMINE | Topco Associates LLC | 8f995561-759a-4837-a82a-640417a6f889 | 2024-12-20 | Warnings | M012 |
| Childrens Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores, Inc. | 50a0eaa5-fa73-4d84-86fc-3546c85cf353 | 2024-12-20 | Warnings | M012 |
| Equate Childrens Multi symptom Cold Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | C.D.M.A., Inc. | 904b7e21-cce5-4b96-afc1-b36f532f98ac | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Equaline | LEVMETAMFETAMINE | Supervalu Inc. | 44f72f34-d0b8-421f-b240-86286de874cf | 2024-12-20 | Warnings | M012 |
| Childrens Tussnex | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 2024-12-19 | Warnings | M012 |
| Vaporising Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | New Pride Corp | f66476d5-036b-0b1c-e053-2a95a90a0a07 | 2024-12-19 | Warnings | M012 |
| Chest Rub Vaporizing Action | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Singhfam Corporation | c6ea663a-9c4f-4d1a-a937-002806a8530a | 2024-12-19 | Warnings | M012 |
| ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION | CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS | Singhfam Corporation | f1e4caee-b50e-a0a6-e053-2a95a90aadce | 2024-12-19 | Warnings | M012 |
| Leader Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | LEADER/Cardinal Health 110, Inc. | ae580e6c-2efd-c788-e053-2995a90a3360 | 2024-12-19 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Service, LLC | 0b6689db-ea34-9a06-e063-6394a90abaf7 | 2024-12-19 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80b9cc1-55f5-76d5-e053-2995a90aa967 | 2024-12-19 | Warnings | M012 |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Home Smart Products | acab200e-48bd-69e1-e053-2995a90afde0 | 2024-12-19 | Warnings | M012 |
| Halls MENTHO-LYPTUS | MENTHOL | Mondelez Global LLC | ff21cf0e-9811-4819-bdfc-17a950e9b114 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold, Flu and Sore Throat | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 7bddce11-c227-4d95-94c1-6f41ecd7285b | 2024-12-19 | Warnings | M012 |
| Childrens Tussnex Multi-symptom cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 9028676e-d725-4afe-aa14-72235825aa17 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold and Sinus | ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 04c6bb6a-d2f8-4322-afba-e240e8090176 | 2024-12-19 | 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 |