FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
68210-4195
11-digit product format
682104195
Labeler code
68210
Product ID
68210-4195_ee8f3551-389f-6270-e053-2a95a90a60a9
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-12-28
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4195IInactivated by FDA2026-10-15
excluded packagepackage68210-419568210-4195-2IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68210-4195-2Nighttime Sleep Aid24 in 1 BLISTER PACKCAPSULE, LIQUID FILLED245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4195NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20241215_39f5b3bd-262d-4253-a4ee-8d286fbb475f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN39f5b3bd-262d-4253-a4ee-8d286fbb475f5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD39f5b3bd-262d-4253-a4ee-8d286fbb475f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4195-26821041950224 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68210-4195-2) 2021-12-280000-00-00NoNoCurrent