FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
69256-916
11-digit product format
692560916
Labeler code
69256
Product ID
69256-916_60685d23-a965-4f9b-8101-35f1098017ac
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Harris Teeter, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
Marketing end
2028-05-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
Nighttime Sleep Aid
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

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
69256-916-32Nighttime Sleep AidMaximum Strength32 in 1 BOTTLE, PLASTICCAPSULE324
69256-916-32Nighttime Sleep AidMaximum Strength1 in 1 BOXCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-916NIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [HARRIS TEETER, LLC]4Current NDC, Legacy NDC, 2 package rows20250316_20f8fe27-f97f-4278-a5a8-79b5fc47ef3b.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 6 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f50cc038-0973-4c4b-84a7-1c68f41c24102025-12-04WarningsExact identifier
application number: M010
Walgreens ChildrensNIGHTTIME COUGHWALGREENS CO.a270cbe3-bf0a-44da-9359-00e218eba2392025-12-01WarningsExact identifier
application number: M010
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.141b00b7-a283-40ab-e063-6294a90aec772025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.1f74e760-9ba9-ac47-e063-6394a90acdff2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLDISCOUNT DRUG MART, INC.116e8192-0c2f-39ed-e063-6294a90abaf32025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGEN16b2edd2-c16b-5713-e063-6394a90acf462025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANY08a38cd2-04ae-1ef9-e063-6294a90a88682025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLKROGER COMPANY0f2c1c6a-29bc-e4a8-e063-6394a90a28cb2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLWhole Foods Market, INC.35acf7d9-e567-996d-e063-6394a90a1cf62025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY048cfa3a-4519-400d-a5ab-ce05c9cc4ec82025-11-26WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe58ce40-ae88-4dc5-9486-e67041f6d8522025-11-26WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEH E Bb72c47a3-cae3-4b98-ae85-e1313b6fd5012025-11-25WarningsExact identifier
application number: M010
Nighttime Wal Flu Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWALGREEN CO.e88f7777-9987-4e3c-a3d5-3da60f190bfd2025-11-25WarningsExact identifier
application number: M010
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALGREENS CO807e8ace-2901-4c5f-96dc-04c755484b952025-11-25WarningsExact identifier
application number: M010
SleepDIPHENHYDRAMINE HCLSalado Sales, Inc.837c02dd-971b-4451-98d8-9c438c9db6962025-11-24WarningsExact identifier
application number: M010
Nighttime SleepAidDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANY3802d57e-7943-c0c2-e063-6394a90a75802025-11-20WarningsExact identifier
application number: M010
Sleep-Aid NighttimeDIPHENHYDRAMINE HCLCVS PHARMACY6bd1ad2e-8f47-412d-8620-b149ad90c2922025-11-17WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporationf8d50b4e-735d-4d91-a18d-be3537e46e992025-11-15WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDECompany name: Topco Associates, LLC7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec2025-10-31WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN20f8fe27-f97f-4278-a5a8-79b5fc47ef3b4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD20f8fe27-f97f-4278-a5a8-79b5fc47ef3b4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY20f8fe27-f97f-4278-a5a8-79b5fc47ef3b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69256-916-32692560916321 BOTTLE, PLASTIC in 1 BOX (69256-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2020-01-312028-05-28NoNoCurrent