FDA.reportPublic FDA data

Sleep Aid

Product NDC
11673-360
11-digit product format
116730360
Labeler code
11673
Product ID
11673-360_4d8e6088-a2f8-44c6-9f3b-8c54feb6e59a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
TARGET Corporation
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-01
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
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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-360-32Sleep Aid1 in 1 BOXCAPSULE15
11673-360-32Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE325
11673-360-60Sleep Aid1 in 1 BOXCAPSULE15
11673-360-60Sleep Aid60 in 1 BOTTLE, PLASTICCAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-360SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [TARGET CORPORATION]5Current NDC, 4 package rows20250321_edfe32b5-9213-4350-9508-2530ee26c5d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNedfe32b5-9213-4350-9508-2530ee26c5d55
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDedfe32b5-9213-4350-9508-2530ee26c5d55
1020477diphenhydramine HCl 50 MG Oral CapsuleSYedfe32b5-9213-4350-9508-2530ee26c5d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11673-360-32116730360321 BOTTLE, PLASTIC in 1 BOX (11673-360-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2023-08-01NoNoCurrent
11673-360-60116730360601 BOTTLE, PLASTIC in 1 BOX (11673-360-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC2023-08-01NoNoCurrent