Nighttime SLEEP AID

Product NDC
51013-181
11-digit product format
510130181
Labeler code
51013
Product ID
51013-181_dc48a41e-2ea8-4e30-b1a9-b7b64f8082bf
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
2016-06-27
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
51013-181-022025-01-30C16284748780-12cef2736-761a-d83d-e063-dadaa90ab31fNighttime SLEEP AID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-181-02Nighttime SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED12
51013-181-02Nighttime SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
51013-181-01Nighttime SLEEP AID100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-181NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20191221_310f58b6-a425-4513-9c0e-5c5439ede527.zip
51013-181NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 1 package rows20241130_2754748f-710b-632e-e063-6294a90a58fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN310f58b6-a425-4513-9c0e-5c5439ede5272
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD310f58b6-a425-4513-9c0e-5c5439ede5272
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2754748f-710b-632e-e063-6294a90a58fd1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2754748f-710b-632e-e063-6294a90a58fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-181-0151013018101100 in 1 BOTTLEHistorical
51013-181-02510130181021 BLISTER PACK in 1 CARTON (51013-181-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2016-06-270000-00-00NoNoCurrent