NiteTime DayTime
- Product NDC
- 41250-597
- 11-digit product format
- 412500597
- Labeler code
- 41250
- Product ID
- 41250-597_fda832aa-eb3a-45e1-8987-036b2d9dc03c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Meijer Distribution Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 DayTime
- Brand name suffix
- Cold and Flu
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41250-597-02 | NiteTime DayTimeCold and Flu | 1 in 1 KIT | KIT | 1 | 6 | |
| 41250-603-40 | NiteTime DayTimeCold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 200 mg in 15mL | 6 |
| 41250-763-40 | NiteTime DayTimeCold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41250-597 | NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241116_d41cb988-d39d-4f0d-bda2-633f2bad6d1f.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 TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8b516736-86ac-47cb-a0ec-038d4c3a0020 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold plus Flu plus Cough Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e85e5eb9-3ecf-4784-999e-111e38e306f5 | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ef8a846d-4b29-4fd8-a683-fada04d0a2b9 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 9761c807-75a1-4498-a8c6-1f2b1c9ffde6 | 2024-11-07 | Warnings | M012 |
| TYLENOL Cold Plus Mucus Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 2024-11-07 | Warnings | M012 |
| Primatene | EPHEDRINE HYDROCHLORIDE | Foundation Consumer Brands | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2024-11-07 | Warnings | M012 |
| Rompe Pecho Max Multi Symptoms | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN | EFFICIENT LABORATORIES INC | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 | 2024-11-07 | Warnings | M012 |
| topcare sinus nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | ca1fefed-e9d7-430a-9da4-972b1a6fb786 | 2024-11-07 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | dd82a389-9ec5-4b3f-a9ea-1a56871ebd17 | 2024-11-07 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 1a8e2e03-e11b-4da1-945b-e2caadea7243 | 2024-11-07 | Warnings | M012 |
| SUDOGEST NASAL DECONGESTANT | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 2024-11-07 | Warnings | M012 |
| up and up childrens allergy melts | DIPHENHYDRAMINE HCL | Target Corporation | f98d1d54-8e11-4bb1-825a-ab5447d37847 | 2024-11-07 | Warnings | M012 |
| good sense severe day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 44130a1b-63cc-42ac-9590-fdf21a12d164 | 2024-11-07 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | a5ff1134-8985-4585-8e61-a5fd5f60afeb | 2024-11-07 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 50528d29-ce8c-4efb-a86c-17246b017db0 | 2024-11-07 | Warnings | M012 |
| cooling severe daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | d4a21760-b2bd-4e26-bff0-6fc1b05d26b3 | 2024-11-07 | Warnings | M012 |
| dg health day time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | 60870311-3234-44ba-95dd-09cf4ea3d508 | 2024-11-07 | Warnings | M012 |
| adult dm max cough and chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution Inc | 3a6855c1-da6d-4fa9-81fe-d2e61355989f | 2024-11-06 | Warnings | M012 |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | e51dfb62-40d0-4bec-9574-90057cb35bcc | 2024-11-06 | Warnings | M012 |
| Foster and Thrive Adult Tussin DM MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Services LLC | 5f6e4d56-4a66-4dbd-97c8-550310dea358 | 2024-11-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | d41cb988-d39d-4f0d-bda2-633f2bad6d1f | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41250-597-02 | 41250059702 | 1 KIT in 1 CARTON (41250-597-02) * 355 mL in 1 BOTTLE (41250-763-40) * 355 mL in 1 BOTTLE (41250-603-40) | 1 kit | 2013-12-30 | 0000-00-00 | No | No | Current |
| 41250-603-40 | 41250060340 | 355 mL in 1 BOTTLE | 355 ml | Historical | ||||
| 41250-763-40 | 41250076340 | 355 mL in 1 BOTTLE | 355 ml | Historical |