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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Marc Glassman, Inc. | e916ef86-ca73-42dd-83dc-6033f56d96f2 | 2025-12-19 | Warnings | M012 |
| Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | e243033b-6603-4c3e-a330-e7c7de51f69d | 2025-12-19 | Warnings | M012 |
| CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 6fa4f913-de83-4175-9dad-0dedab5b69a1 | 2025-12-19 | Warnings | M012 |
| Day-Time COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Discount Drug Mart | 426db906-9aa4-448f-a361-09c1516efc25 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f17385bc-82bb-4183-a4c9-067d8afb3757 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | 9654fdcd-d660-471f-bc5d-aa7dead7a4a8 | 2025-12-19 | Warnings | M012 |
| Night Time Multi-Symptom Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | 8148c2b1-f6ec-4597-8e18-a6597cda5705 | 2025-12-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | NUVICARE LLC | 621ba20e-75c5-42fb-9692-7800f764c978 | 2025-12-19 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL 10 MG | NUVICARE LLC | 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2 | 2025-12-19 | Warnings | M012 |
| COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2025-12-19 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | M012 |
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ac8a20-206c-0024-e063-6394a90a9d06 | 2025-12-18 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ace10f-4257-b20e-e063-6394a90a3c7b | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fabd782-14dc-1d1b-e063-6394a90af428 | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3c6b38-7236-899b-e063-6294a90aabde | 2025-12-18 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | MENTHOL | Chain Drug Marketing Association, Inc. | 8f6ee01c-baad-489f-b2fd-0ef506916ee4 | 2025-12-18 | Warnings | M012 |
| menthol cough drops | MENTHOL | Meijer | 5baeaff7-172c-187a-e053-2a91aa0ab165 | 2025-12-18 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Meijer Distribution Inc. | 3bee752a-4141-1f5b-e054-00144ff8d46c | 2025-12-18 | 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 |