FDA.reportPublic FDA data

Nighttime Sleep-Aid

Product NDC
46122-775
11-digit product format
461220775
Labeler code
46122
Product ID
46122-775_44e8445b-c2fe-375a-e063-6294a90a5b91
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep-Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
46122-775-64Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED13
46122-775-64Nighttime Sleep-Aid60 in 1 BOTTLECAPSULE, LIQUID FILLED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-775-64EA - Each46122-77598379b72-6f5b-4996-8e59-0940c0101eef12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-775NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN]2Current NDC, 2 package rows20250515_16b2edd2-c16b-5713-e063-6394a90acf46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN16b2edd2-c16b-5713-e063-6394a90acf463
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD16b2edd2-c16b-5713-e063-6394a90acf463
1020477diphenhydramine HCl 50 MG Oral CapsuleSY16b2edd2-c16b-5713-e063-6394a90acf463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-775-64461220775641 BOTTLE in 1 CARTON (46122-775-64) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-11NoNoCurrent