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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 0bb006f6-c360-4cd5-81e9-0776d99d79e8 | 2025-07-08 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | 026e530f-e133-4f20-bac5-354fbb647c9e | 2025-07-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY, INC | f59016f3-a8f8-4c95-9414-01440f0574d9 | 2025-07-08 | Warnings | M012 |
| ACTINEL PEDIATRIC | DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL | ACTIPHARMA, LLC | 6bb92d74-4893-40b8-af58-eb307155e876 | 2025-07-08 | Warnings | M012 |
| Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 776b7c67-56c7-420c-82b2-9a176d998396 | 2025-07-08 | Warnings | M012 |
| ACTICON | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 847014ab-86ae-40c5-8e7f-f1ddea14f1b3 | 2025-07-08 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | Cabinet Health, Inc. | 26a51b0e-039c-663c-e063-6394a90ad384 | 2025-07-07 | Warnings | M012 |
| EZ Nite Sleep | DIPHENHYDRAMINE HCL | Safeway, Inc. | 21a68c60-3005-43bb-8ec5-7982239c93f8 | 2025-07-07 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 8188b66a-5405-4e62-bde6-63ebc1f22b16 | 2025-07-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 20e164b8-4cbc-cf3f-e063-6394a90a9d0c | 2025-07-02 | Warnings | M012 |
| 24/7 Life Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT | Lil' Drug Store Products, Inc. | f03430d4-8dbb-4fc0-e053-2a95a90a119d | 2025-07-02 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | 91c803c8-6cf8-4ff6-b376-ea6d65f9f227 | 2025-07-01 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | cc2fdc6b-8319-47c8-b036-37dbd65d5833 | 2025-06-30 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | 91c369b0-8620-4764-a85d-a86402d9489c | 2025-06-30 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | bb9a82b1-ea7a-4d10-bc00-05013e83c4d3 | 2025-06-30 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS, LLC | 202f0661-461c-0333-e063-6294a90a96b5 | 2025-06-28 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | f038b713-0721-2bb5-e053-2a95a90a7842 | 2025-06-26 | 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 |