FDA.reportPublic FDA data

Sleep Aid

Product NDC
51316-367
11-digit product format
513160367
Labeler code
51316
Product ID
51316-367_c98e1f9f-5f74-443d-a11b-1d2b2da9dd75
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-09
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

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
Brand name suffix
Nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe58ce40-ae88-4dc5-9486-e67041f6d852Available 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
51316-367-12Sleep AidNighttime100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
51316-367-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED14

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 TabletPSNfe58ce40-ae88-4dc5-9486-e67041f6d8524
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDfe58ce40-ae88-4dc5-9486-e67041f6d8524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-367-12513160367121 BOTTLE, PLASTIC in 1 CARTON (51316-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2025-07-09NoNoCurrent