FDA.reportPublic FDA data

Sleep Aid

Product NDC
37808-860
11-digit product format
378080860
Labeler code
37808
Product ID
37808-860_28ba2311-7da0-422a-9413-54150442ff8a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
H E B
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-29
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Brand name suffix
Maximum Strength
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-860-12Sleep AidMaximum Strength120 in 1 BOTTLE, PLASTICCAPSULE1207
37808-860-32Sleep AidMaximum Strength32 in 1 BOTTLE, PLASTICCAPSULE327
37808-860-32Sleep AidMaximum Strength1 in 1 BOXCAPSULE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-860SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [H E B]6Current NDC, Legacy NDC, 3 package rows20240410_1069961c-ed3b-471f-a632-81024c37dbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1069961c-ed3b-471f-a632-81024c37dbd97
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1069961c-ed3b-471f-a632-81024c37dbd97
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1069961c-ed3b-471f-a632-81024c37dbd97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-860-1237808086012120 CAPSULE in 1 BOTTLE, PLASTIC (37808-860-12) 120 capsule2020-05-290000-00-00NoNoCurrent
37808-860-32378080860321 BOTTLE, PLASTIC in 1 BOX (37808-860-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent