FDA.reportPublic FDA data

Sleep Aid

Product NDC
49035-704
11-digit product format
490350704
Labeler code
49035
Product ID
49035-704_9996fe9a-d6fe-4fb1-a5f3-fec1caeda1ff
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-18
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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
Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ef35ab9-b6e8-4c88-a623-35ac9d6bd359Available 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
49035-704-02Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION35510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-704SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [WAL-MART STORES INC]9Current NDC, Legacy NDC, 1 package rows20250311_5ef35ab9-b6e8-4c88-a623-35ac9d6bd359.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 9 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)027d7eff-6c83-40f1-9716-231637cdbeba2025-06-12WarningsExact identifier
application number: M010
Nighttime Sleep Aid maximum strengthDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000546e4fda-6eb2-4358-840e-e2473bf7f3522025-06-03WarningsExact identifier
application number: M010
Simply SleepDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC37c606b0-04d5-49f0-886a-3ee2c9b0e9cc2025-06-02WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLWinCo Foods, LLCe9bc5a16-b1fc-4585-8f3b-30ccf43004922025-05-30WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c2025-05-23WarningsExact identifier
application number: M010
Nighttime Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLCare One (Retail Business Services, LLC.)536cd7d6-a470-4614-89c8-6c3ada582a902025-05-23WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLBI-MART2914504a-ed42-4168-9e5c-f49407ed5a302025-05-20WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCardinal Health (Leader) 70000133d6f38-9de7-4104-8175-3933b263afe02025-05-16WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLNORTHEAST PHARMAd2062094-d1b5-38ab-e053-2995a90a56702025-05-15WarningsExact identifier
application number: M010
Nighttime Sleep-aidDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp0fce381f-28ef-4591-a569-c5d599a3b95f2025-05-14WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association54bdb6bc-622c-412a-8365-a1b1c968e13e2025-05-01WarningsExact identifier
application number: M010
Diphenhydramine HCl Maximum StrengthDIPHENHYDRAMINE HCLBi-Martb89c80aa-27ae-4fce-b574-8ee64bbae2752025-05-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI217a211e-b8bf-4119-a094-0e5e733d0b182025-04-21WarningsExact identifier
application number: M010
Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AIDACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company32bedbbc-b939-1bea-e063-6394a90a69342025-04-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)25f32a1c-0687-45e9-8142-96cf635990902025-04-03WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFSA Store Inc. (Caring Mills)9d32a3a1-9528-4de4-9fd1-1d01a1ad93e92025-03-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLWR Group, Inc.d28d0f6d-8029-4e31-b417-4f8f864d840e2025-03-28WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLP & L Development, LLC4144b1a6-aeae-4560-a997-b07206d803502025-03-24WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCa512413c-639b-4846-b016-332a78b50ab72025-03-21WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.1ee41c86-6767-43ca-a5bb-fc685fa662cd2025-03-20WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN5ef35ab9-b6e8-4c88-a623-35ac9d6bd35910
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD5ef35ab9-b6e8-4c88-a623-35ac9d6bd35910
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY5ef35ab9-b6e8-4c88-a623-35ac9d6bd35910
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY5ef35ab9-b6e8-4c88-a623-35ac9d6bd35910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-704-0249035070402355 mL in 1 BOTTLE, PLASTIC (49035-704-02) 355 ml2019-03-180000-00-00NoNoCurrent