FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
51013-142
Requested package NDC
51013-142-16
11-digit product format
510130142
Labeler code
51013
Product ID
51013-142_35a23f15-fbe1-41b2-8395-41505ebf6578
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage51013-14251013-142-16IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51013-142-162025-01-30C16284748780-12cef2736-addd-d83d-e063-dadaa90ab31fNighttime Sleep Aid
51013-142-172025-01-30C16284748780-12cef2736-9991-d83d-e063-dadaa90ab31fNighttime SLEEP AID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-142-16Nighttime Sleep Aid32 in 1 BOTTLECAPSULE, LIQUID FILLED322
51013-142-16Nighttime Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12
51013-142-17Nighttime SLEEP AID64 in 1 BOTTLECAPSULE, LIQUID FILLED642
51013-142-17Nighttime SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-142NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20191212_5d9658b0-99df-4851-a082-84e2e7ddc2c4.zip
51013-142NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20191212_b9f74570-2bda-4659-a1e7-137d04b96dd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN5d9658b0-99df-4851-a082-84e2e7ddc2c42
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNb9f74570-2bda-4659-a1e7-137d04b96dd22
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD5d9658b0-99df-4851-a082-84e2e7ddc2c42
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDb9f74570-2bda-4659-a1e7-137d04b96dd22
1020477diphenhydramine HCl 50 MG Oral CapsuleSY5d9658b0-99df-4851-a082-84e2e7ddc2c42
1020477diphenhydramine HCl 50 MG Oral CapsuleSYb9f74570-2bda-4659-a1e7-137d04b96dd22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-142-16510130142161 BOTTLE in 1 CARTON (51013-142-16) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2016-06-010000-00-00NoNoCurrent