children allergy relief dye free cherry

Product NDC
50090-6163
11-digit product format
500906163
Labeler code
50090
Product ID
50090-6163_93f6f565-a9ba-4bac-9227-b27a57b0204e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
50090-6163_93f6f565-a9ba-4bac-9227-b27a57b0204e
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
children allergy relief dye free cherry
Generic name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Marketing start
2022-04-22
Marketing category
OTC MONOGRAPH DRUG
Application number
M012
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

openFDA Harmonized Identifiers

FieldValues
UniiTC2D6JAD40
Rxcui1049906
Spl Set Id5c6c1809-4c6f-4e8f-a5ae-9796e821d400
Manufacturer NameA-S Medication Solutions

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE147-24-0DIPHENHYDRAMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6163-0500906163001 BOTTLE in 1 CARTON (50090-6163-0) / 118 mL in 1 BOTTLE1 bottle2022-10-110000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SunMark Children Allergy Relief Dye Free CherryA-S Medication Solutions2023-11-01Human OTC Drug Label6