Nighttime Sleep Aid

Product NDC
70000-0616
11-digit product format
700000616
Labeler code
70000
Product ID
70000-0616_e0d650a6-bfa8-4e1f-bfb4-bcfe723227ab
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-28
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0616-1Nighttime Sleep Aid100 in 1 BOTTLE, PLASTICCAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0616-1EA - Each70000-061679b12d03-31a2-4c72-a2a7-400ae367da6312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0616NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [CARDINAL HEALTH (LEADER) 70000]3Current NDC, Legacy NDC, 1 package rows20250519_133d6f38-9de7-4104-8175-3933b263afe0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN133d6f38-9de7-4104-8175-3933b263afe03
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD133d6f38-9de7-4104-8175-3933b263afe03
1020477diphenhydramine HCl 50 MG Oral CapsuleSY133d6f38-9de7-4104-8175-3933b263afe03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0616-170000061601100 CAPSULE in 1 BOTTLE, PLASTIC (70000-0616-1) 100 capsule2022-10-280000-00-00NoNoCurrent