NDC 36800-859

topcare childrens night time cold and cough

Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

topcare childrens night time cold and cough is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 36800-859_b35ae8cc-a5f5-4b2a-9102-816357051d56
• NDC: 36800-859
• Product Type: Human Otc Drug
• Proprietary Name: topcare childrens night time cold and cough
• Generic Name: Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-16
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Topco Associates LLC
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 6 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 36800-859-26

1 BOTTLE in 1 CARTON (36800-859-26) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2019-04-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-859-26 [36800085926]

topcare childrens night time cold and cough SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-16

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: 284d37fd-9604-4874-b99b-a119a4ba8c0f
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • TC2D6JAD40
  • 04JA59TNSJ

NDC Crossover Matching brand name "topcare childrens night time cold and cough" or generic name "Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
36800-859	topcare childrens night time cold and cough	Diphenhydramine hydrochloride, Phenylephrine hydrochloride
0363-0409	Childrens Allergy Plus Congestion	Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
42507-049	Childrens Allergy Plus Congestion	Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
68016-143	Childrens Night Time	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
62558-001	Doctor Manzanilla Cough Suppressant and Nasal Decongestant	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
68016-137	Night Time Cough and Cold Relief	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE