FDA.reportPublic FDA data

Sleep Aid

Product NDC
0363-8020
11-digit product format
003638020
Labeler code
0363
Product ID
0363-8020_bbd1d1a4-9d44-42ca-ac3c-a7cb6cbbcfbb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-10
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

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
0363-8020-02Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3557
0363-8020-45Sleep Aid177 mL in 1 BOTTLE, PLASTICSOLUTION1777
0363-8020-96Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3557
0363-8020-96Sleep Aid2 in 1 PACKAGESOLUTION27
0363-8020-97Sleep Aid2 in 1 CARTONSOLUTION27
0363-8020-97Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3557

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8020SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [WALGREEN COMPANY]5Current NDC, Legacy NDC, 6 package rows20240608_f8f17615-e4ec-49d4-9c0d-581d0fd6feb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNf8f17615-e4ec-49d4-9c0d-581d0fd6feb77
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDf8f17615-e4ec-49d4-9c0d-581d0fd6feb77
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYf8f17615-e4ec-49d4-9c0d-581d0fd6feb77
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYf8f17615-e4ec-49d4-9c0d-581d0fd6feb77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8020-0200363802002355 mL in 1 BOTTLE, PLASTIC (0363-8020-02) 355 ml2022-03-100000-00-00NoNoCurrent
0363-8020-4500363802045177 mL in 1 BOTTLE, PLASTIC (0363-8020-45) 177 ml2022-03-100000-00-00NoNoCurrent
0363-8020-96003638020962 BOTTLE, PLASTIC in 1 PACKAGE (0363-8020-96) / 355 mL in 1 BOTTLE, PLASTIC2022-03-102026-07-31NoNoCurrent
0363-8020-97003638020972 BOTTLE, PLASTIC in 1 CARTON (0363-8020-97) / 355 mL in 1 BOTTLE, PLASTIC2022-03-10NoNoHistorical