Sleep Aid

Product NDC
81522-916
11-digit product format
815220916
Labeler code
81522
Product ID
81522-916_28bc4fe9-aac8-4354-a3ab-c55e6fede243
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
FSA Store Inc. (Caring Mills)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-08
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
81522-916-32Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE325
81522-916-32Sleep Aid1 in 1 BOXCAPSULE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-916SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [FSA STORE INC. (CARING MILLS)]5Current NDC, Legacy NDC, 2 package rows20250331_9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN9d32a3a1-9528-4de4-9fd1-1d01a1ad93e95
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD9d32a3a1-9528-4de4-9fd1-1d01a1ad93e95
1020477diphenhydramine HCl 50 MG Oral CapsuleSY9d32a3a1-9528-4de4-9fd1-1d01a1ad93e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-916-32815220916321 BOTTLE, PLASTIC in 1 BOX (81522-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2021-10-080000-00-00NoNoCurrent