Nighttime Sleep Aid

Product NDC
37808-019
11-digit product format
378080019
Labeler code
37808
Product ID
37808-019_458b7452-2138-6da6-e063-6294a90a0c9c
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
HEB
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
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
Rxcui1049630

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
37808-019-02Nighttime Sleep Aid2 in 1 CARTONTABLET24
37808-019-02Nighttime Sleep Aid16 in 1 BLISTER PACKTABLET164

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-019NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [HEB]3Current NDC, Legacy NDC, 2 package rows20241023_91426a5b-dc01-a27b-e053-2a95a90a8ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN91426a5b-dc01-a27b-e053-2a95a90a8ff84
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD91426a5b-dc01-a27b-e053-2a95a90a8ff84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-019-02378080019022 BLISTER PACK in 1 CARTON (37808-019-02) / 16 TABLET in 1 BLISTER PACK2 blister pack2019-10-310000-00-00NoNoCurrent