FDA.reportPublic FDA data

Sleep Aid

Product NDC
69842-916
11-digit product format
698420916
Labeler code
69842
Product ID
69842-916_2e788cf8-a210-40b1-9644-b2cdbda6c6b6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS Pharmacy
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-916-02Sleep AidNighttime200 in 1 BOTTLE, PLASTICCAPSULE20010
69842-916-32Sleep AidNighttime32 in 1 BOTTLE, PLASTICCAPSULE3210
69842-916-32Sleep AidNighttime1 in 1 BOXCAPSULE110
69842-916-64Sleep AidNighttime1 in 1 BOXCAPSULE110
69842-916-64Sleep AidNighttime64 in 1 BOTTLE, PLASTICCAPSULE6410
69842-916-96Sleep AidNighttime96 in 1 BOTTLE, PLASTICCAPSULE9610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-916SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [CVS PHARMACY]7Current NDC, Legacy NDC, 6 package rows20250521_0be4ef9a-2484-41dd-8bb8-e92d411f1384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN0be4ef9a-2484-41dd-8bb8-e92d411f138410
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD0be4ef9a-2484-41dd-8bb8-e92d411f138410
1020477diphenhydramine HCl 50 MG Oral CapsuleSY0be4ef9a-2484-41dd-8bb8-e92d411f138410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-916-0269842091602200 CAPSULE in 1 BOTTLE, PLASTIC (69842-916-02) 200 capsule2019-11-29NoNoCurrent
69842-916-32698420916321 BOTTLE, PLASTIC in 1 BOX (69842-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2019-11-290000-00-00NoNoCurrent
69842-916-64698420916641 BOTTLE, PLASTIC in 1 BOX (69842-916-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2019-11-290000-00-00NoNoCurrent
69842-916-966984209169696 CAPSULE in 1 BOTTLE, PLASTIC (69842-916-96) 96 capsule2019-11-290000-00-00NoNoCurrent