NDC 36800-200

Topcare ZZZ Sleep

Diphenhydramine Hcl

Topcare ZZZ Sleep 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.

• Product ID: 36800-200_7b66d727-ec8d-4f9f-9ef3-8536017dca90
• NDC: 36800-200
• Product Type: Human Otc Drug
• Proprietary Name: Topcare ZZZ Sleep
• Generic Name: Diphenhydramine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part338
• Labeler Name: Topco Associates LLC
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 36800-200-30

177 mL in 1 BOTTLE (36800-200-30)

• Marketing Start Date: 2013-08-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-200-50 [36800020050]

Topcare ZZZ Sleep SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part338
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-20

NDC 36800-200-30 [36800020030]

Topcare ZZZ Sleep SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part338
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-23

NDC 36800-200-34 [36800020034]

Topcare ZZZ Sleep SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part338
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-09-19

NDC 36800-200-40 [36800020040]

Topcare ZZZ Sleep SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part338
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-20

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/30mL

OpenFDA Data

• SPL SET ID: 27225d04-6deb-436b-89ea-9842c487292e
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • TC2D6JAD40
• RxNorm Concept Unique ID - RxCUI:
  • 1248354
  • 1437306

NDC Crossover Matching brand name "Topcare ZZZ Sleep" or generic name "Diphenhydramine Hcl"

NDC	Brand Name	Generic Name
36800-507	Topcare ZZZ Sleep	Topcare ZZZ Sleep
36800-200	Topcare ZZZ Sleep	Topcare ZZZ Sleep
0113-7379	basic care childrens allergy relief	Diphenhydramine HCl
0113-7186	basic care nighttime sleep aid	Diphenhydramine HCl
0113-7506	basic care nighttime sleep aid	diphenhydramine hcl
0363-0481	Childrens Allergy Dye-Free Wal Dryl	Diphenhydramine HCl
0113-0379	good sense allergy	Diphenhydramine HCl
0113-0052	good sense sleep time	Diphenhydramine HCl
0113-0186	Good Sense Sleep Time	Diphenhydramine HCl
0363-0353	Itch Relief Gel	Diphenhydramine HCl
0363-0236	Nighttime Sleep Aid	Diphenhydramine HCl
0363-0367	Sleep Aid	Diphenhydramine HCl
0363-0189	Sleep II	Diphenhydramine HCl
0363-0190	Wal-Dryl	Diphenhydramine HCl
0363-0418	Wal-Dryl	Diphenhydramine HCl
0363-0329	WAL-DRYL ALLERGY	Diphenhydramine HCl
0363-0020	Wal-Sleep Z	Diphenhydramine HCl