FDA.reportPublic FDA data

berkley and jensen sleep aid

Product NDC
68391-186
11-digit product format
683910186
Labeler code
68391
Product ID
68391-186_d63782ee-785f-4bab-bc05-52b4b8d8fca3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
BJWC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-23
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

Additional Listing Data#

Finished product
Yes
Brand name base
berkley and jensen sleep aid
Listing expiration
2026-12-31

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
68391-186-40berkley and jensen sleep aid3 in 1 CARTONSOLUTION33
68391-186-40berkley and jensen sleep aid355 mL in 1 BOTTLESOLUTION3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-186BERKLEY AND JENSEN SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [BJWC]3Current NDC, Legacy NDC, 2 package rows20241018_e31917a1-e72d-4f71-893f-43046169a32d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNe31917a1-e72d-4f71-893f-43046169a32d3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDe31917a1-e72d-4f71-893f-43046169a32d3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYe31917a1-e72d-4f71-893f-43046169a32d3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYe31917a1-e72d-4f71-893f-43046169a32d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-186-40683910186403 BOTTLE in 1 CARTON (68391-186-40) / 355 mL in 1 BOTTLE3 bottle2020-07-230000-00-00NoNoCurrent