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 |
|---|---|---|---|---|---|---|
| Cold Multi-Symptom Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b | 2026-04-16 | Warnings | M012 |
| Rompe Pecho Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 4f86985c-48f3-2148-e063-6394a90ae2f1 | 2026-04-15 | Warnings | M012 |
| Childrens Daytime Mucus | DEXTROMETHORPHAN HBR | Walgreens | 7a55b7e1-1054-421e-847e-5e4d90d1aebb | 2026-04-15 | Warnings | M012 |
| Childrens Nighttime Mucus | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | dc69f581-27c7-4030-bb18-39685c7691a1 | 2026-04-15 | Warnings | M012 |
| Pseudoephedrine HCl | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | da95c643-7122-4025-977f-42205080e56b | 2026-04-15 | Warnings | M012 |
| Daytime Nighttime Chewable | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | 9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6 | 2026-04-15 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4f7090f4-89c9-c3da-e063-6294a90a4716 | 2026-04-14 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN, PHENYLEPHRINE HCL | Walgreen Company | 2115f095-2d75-4e02-a6af-22dd693e0840 | 2026-04-14 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Lidl US LLC | 00f89eee-0edc-40dc-9297-8645afb91004 | 2026-04-14 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8647c136-a323-453a-8f57-e66938bbf639 | 2026-04-14 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5515148f-3e1d-4b03-89fa-40967d508292 | 2026-04-14 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c70e6506-6c5b-4d3f-ab18-a690840caabc | 2026-04-13 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Walgreen Company | 48387b95-8240-4d6e-842b-cc29cc18709c | 2026-04-13 | Warnings | M012 |
| Sinufrin Plus No Drip Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 4f06c732-1f9f-bfc6-e063-6394a90a53f5 | 2026-04-13 | Warnings | M012 |
| Severe Sinus Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8745d9d8-640d-4e3b-96fe-d25032c1e3ce | 2026-04-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 5a5c5f33-5b70-465d-a38b-6f518af09788 | 2026-04-13 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Publix Super Markets Inc | f2263e38-f686-45ed-bf85-b47f5e1aa982 | 2026-04-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | BETTER LIVING BRANDS, LLC | 46adbf94-5b93-ee64-e063-6294a90a1144 | 2026-04-11 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | 0c79357a-b79d-4952-8e6d-ef3d60dde2fa | 2026-04-10 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 88d27c25-a305-4398-9590-df10d2504b01 | 2026-04-09 | 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 |