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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Family Dollar Services Inc | 8aee8108-a4e0-4956-8e37-6b3b1c5dc683 | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion Relief | GUAIFENESIN | TOPCO ASSOCIATES LLC | b8339617-17ce-4ad7-af38-399ecc74d864 | 2024-12-18 | Warnings | M012 |
| Kroger Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | THE KROGER CO | 976bfdcf-2110-486c-aa6e-cd2067334cdc | 2024-12-18 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | AmerisourceBergen Drug Corp | 79cefd46-bd19-4a1d-9cb1-e85ff0f12494 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Cardinal Health | 8397e1b9-e83e-4c6a-b858-1663c2365840 | 2024-12-18 | Warnings | M012 |
| GNP Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | AmerisourceBergen Drug Corp | 63932e68-b09d-4500-bc1d-cfb2c267df1c | 2024-12-18 | Warnings | M012 |
| Meijer Chest Congestion Relief | GUAIFENESIN | Meijer Distribution Inc. | ae02e0bd-d9e7-495f-b01f-b135b96934a0 | 2024-12-18 | Warnings | M012 |
| Topcare Chest Congestion and Sinus Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | TOPCO ASSOCIATES LLC | b6c0362f-86ca-4f08-ba53-800c6df2c025 | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 10cad9a7-1223-470c-9027-807891217d40 | 2024-12-18 | Warnings | M012 |
| Kroger Mucus Relief | GUAIFENESIN | THE KROGER CO | 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | 41f88b43-3e0a-4650-b167-a72afe6177e8 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Rugby Laboratories | 5da36516-9f94-49cb-9421-0c310abcd116 | 2024-12-18 | 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 |