FDA.reportPublic FDA data

NIGHTTIME SLEEP AID

Product NDC
68210-2010
Requested package NDC
68210-2010-0
11-digit product format
682102010
Labeler code
68210
Product ID
68210-2010_ee50b9d4-f57d-72b3-e053-2a95a90a4610
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
2018-04-16
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-201068210-2010-0IInactivated by FDA2026-09-14

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
68210-2010-0NIGHTTIME SLEEP AID48 in 1 CARTONCAPSULE, LIQUID FILLED487
68210-2010-0NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
68210-2010-1NIGHTTIME SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED17
68210-2010-1NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-2010NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 4 package rows20241215_1d967b2b-99c5-4a01-a961-d3e4723694a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1d967b2b-99c5-4a01-a961-d3e4723694a17
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1d967b2b-99c5-4a01-a961-d3e4723694a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-2010-06821020100048 BLISTER PACK in 1 CARTON (68210-2010-0) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK48 blister pack2018-04-160000-00-00NoNoCurrent