Nighttime Sleep Aid

Product NDC
69607-0916
11-digit product format
696070916
Labeler code
69607
Product ID
69607-0916_b1a15331-6c20-494d-9c50-a27f4702aaa6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
WR Group, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-06
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
Nighttime Sleep Aid
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
69607-0916-6Nighttime Sleep Aid96 in 1 BOTTLE, PLASTICCAPSULE967

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69607-0916NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [WR GROUP, INC.]7Current NDC, Legacy NDC, 1 package rows20250330_d28d0f6d-8029-4e31-b417-4f8f864d840e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNd28d0f6d-8029-4e31-b417-4f8f864d840e7
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDd28d0f6d-8029-4e31-b417-4f8f864d840e7
1020477diphenhydramine HCl 50 MG Oral CapsuleSYd28d0f6d-8029-4e31-b417-4f8f864d840e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69607-0916-66960709160696 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6) 96 capsule2021-08-060000-00-00NoNoCurrent