Nighttime Sleep Aid

Product NDC
72476-916
11-digit product format
724760916
Labeler code
72476
Product ID
72476-916_bdc4ec0b-1b9d-4a6d-b736-eef61a2550b3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
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
Nighttime 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
72476-916-32Nighttime Sleep AidMaximum Strength1 in 1 BOXCAPSULE15
72476-916-32Nighttime Sleep AidMaximum Strength32 in 1 BOTTLE, PLASTICCAPSULE325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-916NIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]5Current NDC, Legacy NDC, 2 package rows20250524_536cd7d6-a470-4614-89c8-6c3ada582a90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN536cd7d6-a470-4614-89c8-6c3ada582a905
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD536cd7d6-a470-4614-89c8-6c3ada582a905
1020477diphenhydramine HCl 50 MG Oral CapsuleSY536cd7d6-a470-4614-89c8-6c3ada582a905

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-916-32724760916321 BOTTLE, PLASTIC in 1 BOX (72476-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-12-270000-00-00NoNoCurrent