FDA.reportPublic FDA data

Wal Som Nighttime Sleep Aid

Product NDC
0363-0816
11-digit product format
003630816
Labeler code
0363
Product ID
0363-0816_34b57fd1-6cc7-081c-e063-6294a90a4dd9
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Walgreens
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-30
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
Wal Som 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, 1090456

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
0363-0816-10Wal Som Nighttime Sleep Aid100 in 1 BOTTLE, PLASTICCAPSULE10010
0363-0816-10Wal Som Nighttime Sleep Aid1 in 1 BOXCAPSULE110
0363-0816-16Wal Som Nighttime Sleep Aid160 in 1 BOTTLE, PLASTICCAPSULE16010
0363-0816-32Wal Som Nighttime Sleep Aid1 in 1 BOXCAPSULE110
0363-0816-32Wal Som Nighttime Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE3210
0363-0816-40Wal Som Nighttime Sleep Aid40 in 1 BOTTLE, PLASTICCAPSULE4010
0363-0816-40Wal Som Nighttime Sleep Aid1 in 1 BOXCAPSULE110
0363-0816-60Wal Som Nighttime Sleep Aid60 in 1 BOTTLE, PLASTICCAPSULE6010
0363-0816-60Wal Som Nighttime Sleep Aid1 in 1 BOXCAPSULE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0816WAL SOM NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [WALGREENS]10Current NDC, Legacy NDC, 9 package rows20250511_ff475a69-dbb2-40a9-b7f4-9c7b7e975d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNff475a69-dbb2-40a9-b7f4-9c7b7e975d1910
1090456Wal-Som Maximum Strength 50 MG Oral CapsulePSNff475a69-dbb2-40a9-b7f4-9c7b7e975d1910
1090456diphenhydramine hydrochloride 50 MG Oral Capsule [Wal-Som Maximum Strength]SBDff475a69-dbb2-40a9-b7f4-9c7b7e975d1910
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDff475a69-dbb2-40a9-b7f4-9c7b7e975d1910
1020477diphenhydramine HCl 50 MG Oral CapsuleSYff475a69-dbb2-40a9-b7f4-9c7b7e975d1910
1090456Wal-Som Maximum Strength 50 MG Oral CapsuleSYff475a69-dbb2-40a9-b7f4-9c7b7e975d1910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0816-10003630816101 BOTTLE, PLASTIC in 1 BOX (0363-0816-10) / 100 CAPSULE in 1 BOTTLE, PLASTIC2019-10-30NoNoCurrent
0363-0816-1600363081616160 CAPSULE in 1 BOTTLE, PLASTIC (0363-0816-16) 160 capsule2019-10-300000-00-00NoNoCurrent
0363-0816-32003630816321 BOTTLE, PLASTIC in 1 BOX (0363-0816-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-10-300000-00-00NoNoCurrent
0363-0816-40003630816401 BOTTLE, PLASTIC in 1 BOX (0363-0816-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC2019-10-30NoNoCurrent
0363-0816-60003630816601 BOTTLE, PLASTIC in 1 BOX (0363-0816-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC2019-10-300000-00-00NoNoCurrent