KROGER Nighttime Sleep-Aid

Product NDC
41226-730
11-digit product format
412260730
Labeler code
41226
Product ID
41226-730_3c28db3f-d545-8844-e063-6394a90a990a
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
KROGER COMPANY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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
41226-730_3c28db3f-d545-8844-e063-6394a90a990a
SPL ID
3c28db3f-d545-8844-e063-6394a90a990a
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
KROGER Nighttime Sleep-Aid
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Marketing start
2024-05-27
Marketing category
OTC MONOGRAPH DRUG
Application number
M010
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

openFDA Harmonized Identifiers

FieldValues
UniiTC2D6JAD40
Rxcui1248354
Spl Set Ida26d63db-8841-47a4-ae09-ac736d7ec357
Manufacturer NameKROGER COMPANY

openFDA Package Details

Package NDCDescriptionMarketing startSample
41226-730-12354 mL in 1 BOTTLE, PLASTIC (41226-730-12)2024-05-27No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-730-1241226073012354 mL in 1 BOTTLE, PLASTIC (41226-730-12) 354 ml2024-05-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
KROGER Nighttime Sleep-Aid 12 FL OZKROGER COMPANY2025-08-12HUMAN OTC DRUG LABEL3