FDA.reportPublic FDA data

NIGHTTIME SLEEP AID

Product NDC
0363-8989
11-digit product format
003638989
Labeler code
0363
Product ID
0363-8989_48c1da66-5540-2aeb-e063-6394a90a1ceb
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREEN COMPANY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-22
Marketing end
2027-08-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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
0363-8989-12NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
0363-8989-12NIGHTTIME SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED17
0363-8989-24NIGHTTIME SLEEP AID2 in 1 CARTONCAPSULE, LIQUID FILLED27
0363-8989-24NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
0363-8989-48NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
0363-8989-48NIGHTTIME SLEEP AID4 in 1 CARTONCAPSULE, LIQUID FILLED47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8989NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]6Current NDC, Legacy NDC, 6 package rows20250101_f000d0b5-8ee8-4db0-99fe-aae5ed20c98e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf000d0b5-8ee8-4db0-99fe-aae5ed20c98e7
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf000d0b5-8ee8-4db0-99fe-aae5ed20c98e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8989-12003638989121 BLISTER PACK in 1 CARTON (0363-8989-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2020-12-222027-08-31NoNoCurrent
0363-8989-24003638989242 BLISTER PACK in 1 CARTON (0363-8989-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2020-12-222027-08-31NoNoCurrent
0363-8989-48003638989484 BLISTER PACK in 1 CARTON (0363-8989-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2020-12-222027-08-31NoNoCurrent