FDA.reportPublic FDA data

Sleep-Aid

Product NDC
69842-470
11-digit product format
698420470
Labeler code
69842
Product ID
69842-470_dcd301b3-063c-41a1-80e3-3faa8077923b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS PHARMACY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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
69842-470-02Sleep-Aid355 mL in 1 BOTTLE, PLASTICSOLUTION35511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-470SLEEP-AID (DIPHENHYDRAMINE HCL) SOLUTION [CVS PHARMACY]10Current NDC, Legacy NDC, 1 package rows20250206_d6f22650-1d85-4b7f-b14b-672a964ff460.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYe96ec4d4-53b9-4636-a58c-1a5923a021ad2025-10-31WarningsExact identifier
application number: M010
GOODNOW SLEEP AIDDIPHENHYDRAMINE HCLGobrands, Inc7d821b7d-6a31-4ff7-b587-51907ba626582025-10-29WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
application number: M010
Sominex MaxDIPHENHYDRAMINE HCLMedtech Products Inc.e8f6991f-c47a-4d12-934b-04fdf092dac32025-10-23WarningsExact identifier
application number: M010
equate NIGHTTIME Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.3d3f2e0c-e141-d49f-e063-6394a90ad0e62025-10-21WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
application number: M010
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)1eb2e4d7-1572-4c0c-888b-342831298cad2025-10-03WarningsExact identifier
application number: M010
AXIV - VroZzzDIPHENHYDRAMINE HYDROCHLORIDEVivunt Pharma LLC131a60cf-02ec-5a5b-e063-6294a90abd1f2025-09-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)485ce8ae-c2b7-462f-9c08-8594cd121f0c2025-09-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREENS35b78063-e717-2ccb-e063-6394a90a18eb2025-09-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationded84160-8f6a-4ad1-93be-efbf3a6c3b8f2025-09-03WarningsExact identifier
application number: M010
QUALITY CHOICE NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)3ce00c99-1a9b-41f1-a99a-35e03730dff02025-08-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f476647-5727-3443-e063-6394a90afd3f2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f477706-0ce2-97b0-e063-6294a90a5c8e2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLH E B1069961c-ed3b-471f-a632-81024c37dbd92025-08-04WarningsExact identifier
application number: M010
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC2ea0b2cf-f055-11f6-e063-6394a90a53642025-08-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLGood Sense (Geiss, Destin & Dunn, Inc.)135482d0-5264-4c81-b43b-8fc931bb02e82025-07-30WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNd6f22650-1d85-4b7f-b14b-672a964ff46011
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDd6f22650-1d85-4b7f-b14b-672a964ff46011
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYd6f22650-1d85-4b7f-b14b-672a964ff46011
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYd6f22650-1d85-4b7f-b14b-672a964ff46011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-470-0269842047002355 mL in 1 BOTTLE, PLASTIC (69842-470-02) 355 ml2019-03-010000-00-00NoNoCurrent