FDA.reportPublic FDA data

Nightime Sleep Aid

Product NDC
58805-006
11-digit product format
588050006
Labeler code
58805
Product ID
58805-006_8a592765-a0be-417d-9ca5-ba530235a986
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Agile Pharmachem
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58805-006-002020-01-31C16284748780-19d75b9d0-de85-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 50mg, USP
58805-006-012020-01-31C16284748780-19d75b9d0-de85-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 50mg, USP
58805-006-022020-01-31C16284748780-19d75b9d0-d5be-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 50mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-006-00Nightime Sleep Aid1 in 1 BAGCAPSULE, LIQUID FILLED12
58805-006-00Nightime Sleep Aid750 in 1 BOXCAPSULE, LIQUID FILLED7502
58805-006-01Nightime Sleep Aid30 in 1 BAGCAPSULE, LIQUID FILLED302
58805-006-01Nightime Sleep Aid750 in 1 BOXCAPSULE, LIQUID FILLED7502
58805-006-02Nightime Sleep Aid750 in 1 BAGCAPSULE, LIQUID FILLED7502
58805-006-02Nightime Sleep Aid48 in 1 BOXCAPSULE, LIQUID FILLED482

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
GELATININACTIVE INGREDIENT2G86QN327LNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
SORBITOLINACTIVE INGREDIENT506T60A25RNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-006NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2Legacy NDC, 4 package rows20150331_114b71f9-36b1-4372-805e-65cbb61f2925.zip
58805-006NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2Legacy NDC, 2 package rows20180521_3f12bd24-8265-44a0-9112-92c026c8e2fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN114b71f9-36b1-4372-805e-65cbb61f29252
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3f12bd24-8265-44a0-9112-92c026c8e2fa2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD114b71f9-36b1-4372-805e-65cbb61f29252
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3f12bd24-8265-44a0-9112-92c026c8e2fa2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY114b71f9-36b1-4372-805e-65cbb61f29252
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3f12bd24-8265-44a0-9112-92c026c8e2fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58805-006-00588050006001 in 1 BAGHistorical
58805-006-015880500060130 in 1 BAGHistorical
58805-006-0258805000602750 in 1 BAGHistorical