NDC 58809-750

Childrens PediaClear Cough

Diphenhydramine Hydrochloride

Childrens PediaClear Cough is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Diphenhydramine Hydrochloride.

• Product ID: 58809-750_19013211-2381-48b9-b9d1-c3eb88aae307
• NDC: 58809-750
• Product Type: Human Otc Drug
• Proprietary Name: Childrens PediaClear Cough
• Generic Name: Diphenhydramine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GM Pharmaceuticals, INC
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE
• Active Ingredient Strength: 6 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58809-750-50

50 mL in 1 BOTTLE, DROPPER (58809-750-50)

• Marketing Start Date: 2019-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58809-750-50 [58809075050]

Childrens PediaClear Cough LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-25

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg/mL

OpenFDA Data

• SPL SET ID: 158246bb-2c7e-41a1-8798-fa21da20f93b
• Manufacturer:
  • GM Pharmaceuticals, INC
• UNII:
  • TC2D6JAD40
• RxNorm Concept Unique ID - RxCUI:
  • 1789740

NDC Crossover Matching brand name "Childrens PediaClear Cough" or generic name "Diphenhydramine Hydrochloride"

NDC	Brand Name	Generic Name
58809-750	Childrens PediaClear Cough	Childrens PediaClear Cough
0363-7100	Adult Allergy Relief	Diphenhydramine Hydrochloride
0363-0100	ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE
0113-7479	basic care allergy relief	Diphenhydramine Hydrochloride
0363-0710	childrens Allergy Dye Free Wal Dryl	Diphenhydramine hydrochloride
0363-0004	Childrens WAL-DRYL	Diphenhydramine Hydrochloride
0121-0865	Diphenhydramine HCl Oral Solution	diphenhydramine hydrochloride
0121-1730	Diphenhydramine HCl Oral Solution	diphenhydramine hydrochloride
0121-0489	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE
0121-0978	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE
0185-0648	diphenhydramine hydrochloride	diphenhydramine hydrochloride
0185-0649	diphenhydramine hydrochloride	diphenhydramine hydrochloride
0363-0293	Dye Free Wal Dryl Allergy	Diphenhydramine Hydrochloride
0363-0753	Dye Free Wal Sleep Z	DIPHENHYDRAMINE HYDROCHLORIDE
0113-0462	Good Sense Allergy Relief	diphenhydramine hydrochloride
0113-0479	good sense allergy relief	Diphenhydramine Hydrochloride
0113-0431	good sense nighttime sleep aid	Diphenhydramine Hydrochloride
0113-1909	good sense sleep aid	diphenhydramine hydrochloride
0363-0092	Wal Dryl	Diphenhydramine Hydrochloride
0363-0379	wal dryl allergy	Diphenhydramine Hydrochloride
0363-0060	Wal-Sleep Z	Diphenhydramine Hydrochloride
0363-0223	Wal-Som	Diphenhydramine hydrochloride