FDA.reportPublic FDA data

Sleep Aid

Product NDC
21130-816
11-digit product format
211300816
Labeler code
21130
Product ID
21130-816_ba39e886-edf7-4c7d-90d8-6331f662f208
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Safeway, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Marketing end
2027-03-29
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid

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
21130-816-32Sleep Aid1 in 1 BOXCAPSULE17
21130-816-32Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE327
21130-816-96Sleep Aid96 in 1 BOTTLE, PLASTICCAPSULE967

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-816SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [SAFEWAY, INC.]5Current NDC, Legacy NDC, 3 package rows20241027_65d1a199-0a8e-41b1-a767-f16e3f91ac94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN65d1a199-0a8e-41b1-a767-f16e3f91ac947
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD65d1a199-0a8e-41b1-a767-f16e3f91ac947
1020477diphenhydramine HCl 50 MG Oral CapsuleSY65d1a199-0a8e-41b1-a767-f16e3f91ac947

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-816-32211300816321 BOTTLE, PLASTIC in 1 BOX (21130-816-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-11-292027-03-29NoNoCurrent
21130-816-962113008169696 CAPSULE in 1 BOTTLE, PLASTIC (21130-816-96) 96 capsule2019-11-292027-03-29NoNoCurrent