Nighttime Sleep Aid

Product NDC
59726-916
11-digit product format
597260916
Labeler code
59726
Product ID
59726-916_30c5984c-cccc-4982-9fec-5de1db36621f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
P & L Development, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
Marketing end
2027-03-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep Aid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
59726-916-32Nighttime Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE325
59726-916-32Nighttime Sleep Aid1 in 1 BOXCAPSULE15
59726-916-64Nighttime Sleep Aid64 in 1 BOTTLE, PLASTICCAPSULE645
59726-916-64Nighttime Sleep Aid1 in 1 BOXCAPSULE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-916NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [P & L DEVELOPMENT, LLC]4Current NDC, Legacy NDC, 4 package rows20240501_59c063ad-6ea3-4f1d-a20e-5e5e062a9098.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN59c063ad-6ea3-4f1d-a20e-5e5e062a90985
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD59c063ad-6ea3-4f1d-a20e-5e5e062a90985
1020477diphenhydramine HCl 50 MG Oral CapsuleSY59c063ad-6ea3-4f1d-a20e-5e5e062a90985

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-916-32597260916321 BOTTLE, PLASTIC in 1 BOX (59726-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2021-03-262027-03-26NoNoCurrent
59726-916-64597260916641 BOTTLE, PLASTIC in 1 BOX (59726-916-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2021-03-262027-03-26NoNoCurrent