Sleep Aid

Product NDC
63868-900
11-digit product format
638680900
Labeler code
63868
Product ID
63868-900_69c0cc14-b0fa-48bc-9bbb-95f4d2d87bfd
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
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
Sleep Aid
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

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
63868-900-32Sleep AidMaximum Strength1 in 1 BOXCAPSULE13
63868-900-32Sleep AidMaximum Strength32 in 1 BOTTLE, PLASTICCAPSULE323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-900SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20240423_b8757d18-6c7d-45de-925a-e2814625f749.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNb8757d18-6c7d-45de-925a-e2814625f7493
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDb8757d18-6c7d-45de-925a-e2814625f7493
1020477diphenhydramine HCl 50 MG Oral CapsuleSYb8757d18-6c7d-45de-925a-e2814625f7493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-900-32638680900321 BOTTLE, PLASTIC in 1 BOX (63868-900-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-12-270000-00-00NoNoCurrent