FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
30142-095
11-digit product format
301420095
Labeler code
30142
Product ID
30142-095_2e2d16a4-0aee-451f-ba9f-7019d5756bbc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-095-02Nighttime Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3554
30142-095-96Nighttime Sleep Aid2 in 1 PACKAGESOLUTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-095NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [KROGER COMPANY]3Current NDC, 2 package rows20250512_b71bb567-5605-430b-b3fa-048fe9bbe8ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNb71bb567-5605-430b-b3fa-048fe9bbe8ff4
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDb71bb567-5605-430b-b3fa-048fe9bbe8ff4
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYb71bb567-5605-430b-b3fa-048fe9bbe8ff4
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYb71bb567-5605-430b-b3fa-048fe9bbe8ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-095-0230142009502355 mL in 1 BOTTLE, PLASTIC355 mlHistorical
30142-095-96301420095962 BOTTLE, PLASTIC in 1 PACKAGE (30142-095-96) / 355 mL in 1 BOTTLE, PLASTIC (30142-095-02) 2024-05-22NoNoHistorical