FDA.reportPublic FDA data

NIGHTTIME SLEEP AID

Product NDC
11822-1565
11-digit product format
118221565
Labeler code
11822
Product ID
11822-1565_ee4fa5a0-1d56-1248-e053-2a95a90a3a1b
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RITE AID CORPORATION
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-04
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

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
11822-1565-12026-01-29C16284748780-149896155-a6a2-586f-e063-e6dba90add90NIGHTTIME SLEEP-AID
11822-1565-22026-01-29C16284748780-149896155-a6a2-586f-e063-e6dba90add90NIGHTTIME SLEEP-AID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1565-1NIGHTTIME SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED17
11822-1565-1NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
11822-1565-2NIGHTTIME SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
11822-1565-2NIGHTTIME SLEEP AID2 in 1 CARTONCAPSULE, LIQUID FILLED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1565NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]7Legacy NDC, 4 package rows20250101_b25f8cf0-48ce-4478-aab3-4c58e57e353c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNb25f8cf0-48ce-4478-aab3-4c58e57e353c7
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDb25f8cf0-48ce-4478-aab3-4c58e57e353c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1565-1118221565011 BLISTER PACK in 1 CARTON (11822-1565-1) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2021-05-040000-00-00NoNoCurrent
11822-1565-2118221565022 BLISTER PACK in 1 CARTON (11822-1565-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-05-040000-00-00NoNoCurrent