FDA.reportPublic FDA data

nighttime sleep-aid

Product NDC
69452-322
11-digit product format
694520322
Labeler code
69452
Product ID
69452-322_0d63c644-46c2-b4c0-e063-6394a90a9dd3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-27
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
c0074c77-287e-6c26-e053-2995a90a4d31Available on FDA.report

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
69452-322-79nighttime sleep-aid160 in 1 BOTTLECAPSULE, LIQUID FILLED1604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-322NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20231226_c0074c77-287e-6c26-e053-2995a90a4d31.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 3 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLRite Aid Corporationfbedb50d-b96f-4ce4-a1dc-d2b357cf6de12026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacy0be4ef9a-2484-41dd-8bb8-e92d411f13842026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGENca052b38-de38-7bf0-e053-2995a90a4e852026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCe68d96c8-21c5-406c-b22c-3e384027c79f2026-05-07WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLKroger Companyb71bb567-5605-430b-b3fa-048fe9bbe8ff2026-05-04WarningsExact identifier
application number: M010
Sleep II Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyed864c84-a430-4ca8-87e8-04f1c1df538b2026-05-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyf8f17615-e4ec-49d4-9c0d-581d0fd6feb72026-04-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.888dc258-d5a3-4b62-aea1-c81ea29ff6f52026-04-28WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen8f1cb631-4633-4ef5-868e-48a46ab311a42026-04-27WarningsExact identifier
application number: M010
Nightime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBETTER LIVING BRANDS LLC.202bb1ff-3273-4872-e063-6294a90abebb2026-04-11WarningsExact identifier
application number: M010
Vicks ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1be2f00b-5bdd-82e7-e063-6394a90ab9a52026-04-06WarningsExact identifier
application number: M010
Night Time Sleep AidDIPHENHYDRAMINE HCLHyVee Inccf94fa56-01a5-4d6c-ad08-38b0ea3633992026-04-03WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICE84ec323d-0523-41e8-856c-e02d6afdc9ec2026-04-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6c9b7576-428a-4884-8331-bb312c9046bd2026-04-01WarningsExact identifier
application number: M010
Calmco Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC471d4c70-813a-19de-e063-6394a90aeb252026-03-31WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLThe Kroger Co.0db543bb-c6c3-4370-a70c-e1652781fd7d2026-03-25WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 50MGGrocery Outlet57a751e9-d8b6-4527-8537-bc4be718f5ec2026-03-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companydf7a43d1-83a7-4e86-baef-4b9d1ebf0dbb2026-03-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.4454df6a-931f-3f03-e063-6294a90afe732026-03-14WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNc0074c77-287e-6c26-e053-2995a90a4d314
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDc0074c77-287e-6c26-e053-2995a90a4d314
1020477diphenhydramine HCl 50 MG Oral CapsuleSYc0074c77-287e-6c26-e053-2995a90a4d314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-322-7969452032279160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79) 2021-04-270000-00-00NoNoCurrent