FDA.reportPublic FDA data

Unisom SleepMelts Nighttime Sleep-Aid

Product NDC
63868-393
11-digit product format
638680393
Labeler code
63868
Product ID
63868-393_451d2a55-5219-9ce6-e063-6394a90a2d06
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-07
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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
Unisom SleepMelts Nighttime Sleep-Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1093098, 1093102

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-393-24Unisom SleepMelts Nighttime Sleep-Aid24 in 1 BLISTER PACKTABLET, CHEWABLE246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-393UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Current NDC, Legacy NDC, 1 package rows20241220_f50cc038-0973-4c4b-84a7-1c68f41c2410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093098diphenhydrAMINE HCl 25 MG Disintegrating Oral TabletPSNf50cc038-0973-4c4b-84a7-1c68f41c24106
1093102Unisom SleepMelts 25 MG Disintegrating Oral TabletPSNf50cc038-0973-4c4b-84a7-1c68f41c24106
1093102diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]SBDf50cc038-0973-4c4b-84a7-1c68f41c24106
1093098diphenhydramine hydrochloride 25 MG Disintegrating Oral TabletSCDf50cc038-0973-4c4b-84a7-1c68f41c24106
1093102Unisom Sleep 25 MG Disintegrating Oral TabletSYf50cc038-0973-4c4b-84a7-1c68f41c24106
1093102Unisom SleepMelts 25 MG Disintegrating Oral TabletSYf50cc038-0973-4c4b-84a7-1c68f41c24106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-393-246386803932424 TABLET, CHEWABLE in 1 BLISTER PACK (63868-393-24) 2019-01-070000-00-00NoNoCurrent