Nighttime Sleep Aid

Product NDC
71679-110
11-digit product format
716790110
Labeler code
71679
Product ID
71679-110_37d37296-6f58-cb2f-e063-6394a90adfbc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Health Pharma USA LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-18
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
71679-110-03Nighttime Sleep Aid300 in 1 BOTTLETABLET, COATED30011
71679-110-06Nighttime Sleep Aid600 in 1 BOTTLETABLET, COATED60011
71679-110-10Nighttime Sleep Aid1000 in 1 BOTTLETABLET, COATED100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71679-110NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET, COATED [HEALTH PHARMA USA LLC]5Current NDC, Legacy NDC, 3 package rows20231031_d659f747-9790-8bd6-e053-2995a90ae793.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd659f747-9790-8bd6-e053-2995a90ae79311
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd659f747-9790-8bd6-e053-2995a90ae79311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71679-110-0371679011003300 TABLET, COATED in 1 BOTTLE (71679-110-03) 2025-06-18NoNoCurrent
71679-110-0671679011006600 TABLET, COATED in 1 BOTTLE (71679-110-06) 2025-06-180000-00-00NoNoCurrent
71679-110-10716790110101000 TABLET, COATED in 1 BOTTLE (71679-110-10) 2025-06-180000-00-00NoNoCurrent