NDC 57243-189

Sleep

Diphenhydramine Hcl

Sleep is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Salado Sales, Inc.. The primary component is Diphenhydramine Hydrochloride.

• Product ID: 57243-189_061a8864-29bc-459e-b405-5a31e096e2d1
• NDC: 57243-189
• Product Type: Human Otc Drug
• Proprietary Name: Sleep
• Generic Name: Diphenhydramine Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1990-04-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part338
• Labeler Name: Salado Sales, Inc.
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 57243-189-21

2 BLISTER PACK in 1 CARTON (57243-189-21) > 8 TABLET in 1 BLISTER PACK

• Marketing Start Date: 1990-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57243-189-21 [57243018921]

Sleep TABLET

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part338
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 1990-04-10

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 837c02dd-971b-4451-98d8-9c438c9db696
• Manufacturer:
  • Salado Sales, Inc.
• UNII:
  • TC2D6JAD40
• RxNorm Concept Unique ID - RxCUI:
  • 1049630
• UPC Code:
  • 0761706166055

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

NDC	Brand Name	Generic Name
69779-012	sleep	sleep
54973-3206	Sleep	Sleep
57243-189	Sleep	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