FDA.reportPublic FDA data

Sleep Aid

Product NDC
69842-916
Requested package NDC
69842-916-64
11-digit product format
698420916
Labeler code
69842
Product ID
69842-916_2e788cf8-a210-40b1-9644-b2cdbda6c6b6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS Pharmacy
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
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

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Brand name suffix
Nighttime
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
0be4ef9a-2484-41dd-8bb8-e92d411f1384Available 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
69842-916-02Sleep AidNighttime200 in 1 BOTTLE, PLASTICCAPSULE20010
69842-916-32Sleep AidNighttime32 in 1 BOTTLE, PLASTICCAPSULE3210
69842-916-32Sleep AidNighttime1 in 1 BOXCAPSULE110
69842-916-64Sleep AidNighttime1 in 1 BOXCAPSULE110
69842-916-64Sleep AidNighttime64 in 1 BOTTLE, PLASTICCAPSULE6410
69842-916-96Sleep AidNighttime96 in 1 BOTTLE, PLASTICCAPSULE9610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-916SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [CVS PHARMACY]7Current NDC, Legacy NDC, 6 package rows20250521_0be4ef9a-2484-41dd-8bb8-e92d411f1384.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 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLBi-Mart1b40e794-089f-4546-8f8d-ba7016cd4e7f2026-06-22WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWal-Mart Stores Inccfddfdeb-701f-452d-876d-8003e6fcefe32026-06-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-05-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOPCO ASSOCIATES LLC9558cc42-d27d-42af-b0a7-44cad025165d2026-05-21WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN0be4ef9a-2484-41dd-8bb8-e92d411f138410
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD0be4ef9a-2484-41dd-8bb8-e92d411f138410
1020477diphenhydramine HCl 50 MG Oral CapsuleSY0be4ef9a-2484-41dd-8bb8-e92d411f138410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-916-64698420916641 BOTTLE, PLASTIC in 1 BOX (69842-916-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2019-11-290000-00-00NoNoCurrent