FDA.reportPublic FDA data

Sleep Aid

Product NDC
46122-651
11-digit product format
461220651
Labeler code
46122
Product ID
46122-651_3cb18157-c1fe-4afa-99f2-9f55ac9efa92
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-29
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-65146122-651-78DDiscontinued by firm2026-10-15

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 HYDROCHLORIDE25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-651-62Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED128
46122-651-62Sleep Aid2 in 1 CARTONTABLET, FILM COATED28
46122-651-78Sleep Aid1 in 1 CARTONTABLET, FILM COATED18
46122-651-78Sleep Aid100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-651-62EA - Each46122-651e4deb95c-d554-4463-b2bc-7a6d850c1d4b12021-07-15
46122-651-78EA - Each46122-65150fb5ecc-9149-4e02-8549-59871985a6a512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-651SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [AMERISOURCE BERGEN]7Current NDC, Legacy NDC, 4 package rows20240711_147adc14-ca7c-45f5-9925-ea569edbfe96.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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)40e73317-5126-4961-8f28-60899ffbec5a2024-02-20WarningsExact identifier
application number: M010
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)2424fb95-06e2-49e7-aea0-7797a37aef4d2024-02-20WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf5b609e1-e63b-2e3b-e053-2995a90a76b92024-02-12WarningsExact identifier
application number: M010
Kroger Nighttime Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.f0f3f58d-9457-4697-98e6-ef52d350cf672024-01-29WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health88feea1d-c961-45e9-b9a6-1418b970aaba2024-01-16WarningsExact identifier
application number: M010
Sleep-Aid Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leader4283558d-62df-4297-bc85-a4e06681a9202024-01-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketd3f35102-94ed-4da0-9c29-312e5468fa052023-12-29WarningsExact identifier
application number: M010
nighttime sleep-aidDIPHENHYDRAMINE HCLBionpharma Inc.c0074c77-287e-6c26-e053-2995a90a4d312023-12-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYRAMINE HYDROCHLORIDETARGET CORPORATIONfac83dad-f6fd-3316-e053-6394a90a99aa2023-12-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENYDRAMINE HYDROCHLORIDETARGET CORPORATIONfc7ed67f-bac9-f9ed-e053-6294a90ad9a12023-12-16WarningsExact identifier
application number: M010
Sleep-Aid, Circle KDIPHENHYDRAMINE HCL CAPLET, 25MGLil' Drug Store Products, Inc.d3ad24c4-44ba-6451-e053-2a95a90a13392023-12-14WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANYfed2f7ae-2829-f967-e053-6294a90adc0a2023-10-12WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDBetter Living Brands LLC2b730fa5-47f9-468d-86ed-0d49d9cd8dc42023-07-06WarningsExact identifier
application number: M010
Diphenhydramine HCl 25mgSLEEP AIDAllegiant Health2890e4ba-d642-437d-8a86-24996a74e0272021-11-23WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDAllegiant Health9a0b347e-5719-42f3-9050-df5165495e882021-10-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAllegiant Healthec57db48-0f3a-4b12-8633-b45a4366c2692020-11-06WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN147adc14-ca7c-45f5-9925-ea569edbfe968
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD147adc14-ca7c-45f5-9925-ea569edbfe968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-651-62461220651622 BLISTER PACK in 1 CARTON (46122-651-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-07-290000-00-00NoNoCurrent
46122-651-78461220651781 BOTTLE, PLASTIC in 1 CARTON (46122-651-78) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-07-290000-00-00NoNoCurrent