NDC 36800-594

topcare nite time cold and flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

topcare nite time cold and flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 36800-594_0827eb15-2d01-43cc-a390-ff625eb71f33
• NDC: 36800-594
• Product Type: Human Otc Drug
• Proprietary Name: topcare nite time cold and flu
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Topco Associates LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 36800-594-40

355 mL in 1 BOTTLE (36800-594-40)

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-594-40 [36800059440]

topcare nite time cold and flu SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: 679017b8-9d79-4a40-8953-1bdf3b5fd57e
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH

NDC Crossover Matching brand name "topcare nite time cold and flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
36800-143	topcare nite time cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
36800-291	topcare nite time cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
36800-307	topcare nite time cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
36800-560	topcare nite time cold and flu	acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
36800-594	topcare nite time cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
36800-614	Topcare Nite Time Cold and Flu	Topcare Nite Time Cold and Flu
36800-908	TopCare Nite Time Cold and flu	TopCare Nite Time Cold and flu
36800-763	Topcare Nite Time Cold and Flu	Topcare Nite Time Cold and Flu
0280-1580	Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1581	Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1600	Alka-Seltzer Plus Maximum Strength Night Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1640	Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0280-1610	Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1620	Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1222	Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Night	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0113-7501	basic care nighttime cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0113-7763	basic care nigttime cold and flu severe	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
11822-0591	cold and flu relief	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0363-1658	Dye Free Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
36800-411	Night Time Cold and Flu Severe	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0363-5900	nighttime severe cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
21130-595	signature care nighttime severe cold and flu relief	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
11673-763	up and up nighttime severe cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
11673-251	up and up nighttime vapor ice cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride