NDC 50580-571
TYLENOL COLD MAX NIGHT
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
TYLENOL COLD MAX NIGHT is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.
| Product ID | 50580-571_f1dcf657-2dbf-4e38-99ea-27767cfb0707 |
| NDC | 50580-571 |
| Product Type | Human Otc Drug |
| Proprietary Name | TYLENOL COLD MAX NIGHT |
| Generic Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-04-13 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 50580-571-01
240 mL in 1 BOTTLE, PLASTIC (50580-571-01)
| Marketing Start Date | 2015-04-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50580-571-01 [50580057101]
TYLENOL COLD MAX NIGHT SOLUTION
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-04-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
OpenFDA Data
| SPL SET ID: | eecc9d05-ce7a-4c6e-9dd2-9a6925efc77c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "TYLENOL COLD MAX NIGHT" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0280-0922 | Alka-Seltzer Plus Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 36800-848 | Cold and Flu Severe Nighttime | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride |
| 63824-593 | Mucinex Fast-Max | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride |
| 0363-6140 | NightTime Cold | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 37000-530 | NyQuil Severe plus | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 69423-989 | NyQuil VapoCOOL SEVERE | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 0363-0114 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 0363-8997 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 36800-659 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 49035-624 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 49035-669 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 68210-4087 | SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE |
| 37000-528 | Sinex Severe plus | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 64336-175 | Sinex Severe plus | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 50580-571 | TYLENOL COLD MAX | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride |
| 50580-369 | Tylenol Cold plus Flu plus Cough | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride |
| 37000-531 | Vicks Formula 44 VapoCool | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 37000-812 | Vicks NyQuil | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride |
| 37000-815 | Vicks NyQuil | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
| 0363-6111 | Walgreen Nighttime Cold and Flu | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride |
Trademark Results [TYLENOL COLD MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYLENOL COLD MAX 86144356 5018281 Live/Registered |
Johnson & Johnson 2013-12-16 |
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