FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
70000-0616
11-digit product format
700000616
Labeler code
70000
Product ID
70000-0616_e0d650a6-bfa8-4e1f-bfb4-bcfe723227ab
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
Nighttime Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
133d6f38-9de7-4104-8175-3933b263afe0Available on FDA.report

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
70000-0616-1Nighttime Sleep Aid100 in 1 BOTTLE, PLASTICCAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0616-1EA - Each70000-061679b12d03-31a2-4c72-a2a7-400ae367da6312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0616NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [CARDINAL HEALTH (LEADER) 70000]3Current NDC, Legacy NDC, 1 package rows20250519_133d6f38-9de7-4104-8175-3933b263afe0.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 CapsulePSN133d6f38-9de7-4104-8175-3933b263afe03
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD133d6f38-9de7-4104-8175-3933b263afe03
1020477diphenhydramine HCl 50 MG Oral CapsuleSY133d6f38-9de7-4104-8175-3933b263afe03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0616-170000061601100 CAPSULE in 1 BOTTLE, PLASTIC (70000-0616-1) 100 capsule2022-10-280000-00-00NoNoCurrent