FDA.reportPublic FDA data

CVS Health Nighttime Sleep Aid

Product NDC
69842-753
11-digit product format
698420753
Labeler code
69842
Product ID
69842-753_03f521f4-d35f-4f66-b3ad-7e58a244eb93
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy,Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-10-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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
CVS Health Nighttime Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
69842-753-12CVS Health Nighttime Sleep Aid354 mL in 1 BOTTLE, PLASTICLIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-753CVS HEALTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]1Current NDC, Legacy NDC, 1 package rows20171018_03f521f4-d35f-4f66-b3ad-7e58a244eb93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN03f521f4-d35f-4f66-b3ad-7e58a244eb931
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD03f521f4-d35f-4f66-b3ad-7e58a244eb931
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY03f521f4-d35f-4f66-b3ad-7e58a244eb931
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY03f521f4-d35f-4f66-b3ad-7e58a244eb931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-753-1269842075312354 mL in 1 BOTTLE, PLASTIC (69842-753-12) 354 ml2017-10-110000-00-00NoNoCurrent