NDC 42787-104

BENALDRYL

Diphenhydramine Hcl

BENALDRYL is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Ajes Pharmaceuticals,llc. The primary component is Diphenhydramine Hydrochloride.

• Product ID: 42787-104_33e8167f-3d6f-42eb-be0e-abe2dcb25f5d
• NDC: 42787-104
• Product Type: Human Otc Drug
• Proprietary Name: BENALDRYL
• Generic Name: Diphenhydramine Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: AJES PHARMACEUTICALS,LLC
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/250mg
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42787-104-12

1 BOTTLE, PLASTIC in 1 CARTON (42787-104-12) > 25000 mg in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2012-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42787-104-30 [42787010430]

BENALDRYL TABLET

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-09-01
• Inactivation Date: 2020-01-31

NDC 42787-104-12 [42787010412]

BENALDRYL TABLET

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-09-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/250mg

OpenFDA Data

• SPL SET ID: a5df4f25-fa80-49ac-922d-60a6d1abe8d5
• Manufacturer:
  • AJES PHARMACEUTICALS,LLC
• UNII:
  • TC2D6JAD40
• RxNorm Concept Unique ID - RxCUI:
  • 1049630

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

NDC	Brand Name	Generic Name
42787-104	BENALDRYL	BENALDRYL
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