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 |
|---|---|---|---|---|---|---|
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | DeMoulas Market Basket | e92d2f64-9690-42d3-b787-cafade3a8999 | 2023-12-29 | Warnings | M012 |
| Cold and Sinus Maxium Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc | 2023-12-29 | Warnings | M012 |
| Cold, Flu and Sore Throat Maxium Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | d98029c0-ccd9-47e1-996f-c7786cd4ecca | 2023-12-29 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 0f2be061-bd0a-4e62-b994-6d0768ea647a | 2023-12-29 | Warnings | M012 |
| Tussin CF Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | c19b9997-4037-48f3-b905-86da421a292d | 2023-12-29 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | 0239ada0-644d-4ef4-a3b8-df70246a3bc2 | 2023-12-21 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | a698502d-c1c5-41ca-8142-74338b834c8b | 2023-12-21 | Warnings | M012 |
| Father Johns Cough Medicine Plus | NASAL DECONGESTANT | Oakhurst Company | 8b8aab0f-251b-6bd8-e053-2995a90ad748 | 2023-12-18 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Oakhurst Company | 8b8a249d-55af-cc98-e053-2995a90a431d | 2023-12-18 | Warnings | M012 |
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79d92d2-d73c-d44f-e053-2995a90a03d9 | 2023-12-15 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL TABLET | Lil' Drug Store Products, Inc. | e5339c39-1d66-b283-e053-2995a90a4317 | 2023-12-15 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Humco Holding Group, Inc | a7b0669f-8da1-5a44-e053-2995a90a84d9 | 2023-12-15 | Warnings | M012 |
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | M012 |
| Allergy, Circle K | DIPHENHYDRAMINE HCL 25MG TABLET | Lil' Drug Store Products, Inc. | d1f370ac-e7f4-baf7-e053-2995a90a1e50 | 2023-12-14 | Warnings | M012 |
| Circle K Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | a6a1e3d9-575c-4adf-beb6-c9719de55c67 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Sinus Severe, Circle K | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store products, Inc. | e78c456f-f62e-596d-e053-2995a90a2397 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Max Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79f1a92-d8ea-e3f9-e053-2a95a90a2d37 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | bcc1a001-4176-485d-aaf0-2037ca65c6b8 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | edb49b17-06a7-4c25-bc7c-d62c1deac7f1 | 2023-12-13 | Warnings | M012 |
| Family Wellness Oxymetazoline No Drip | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 0c006b1c-8ab2-4b9c-8738-e7001c1bb47d | 2023-12-11 | 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 |