FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
50804-860
11-digit product format
508040860
Labeler code
50804
Product ID
50804-860_292a1bbf-5c3c-44f8-960b-64b60de88b39
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
Marketing end
2026-12-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-860-32Nighttime Sleep Aid1 in 1 BOXCAPSULE15
50804-860-32Nighttime Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE325

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-860-32EA - Each50804-86015e48571-0199-4a0c-9d0d-30ee1a54fc4812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-860NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]4Current NDC, Legacy NDC, 2 package rows20240404_135482d0-5264-4c81-b43b-8fc931bb02e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN135482d0-5264-4c81-b43b-8fc931bb02e85
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD135482d0-5264-4c81-b43b-8fc931bb02e85
1020477diphenhydramine HCl 50 MG Oral CapsuleSY135482d0-5264-4c81-b43b-8fc931bb02e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-860-32508040860321 BOTTLE, PLASTIC in 1 BOX (50804-860-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2021-04-302026-12-30NoNoCurrent