FDA.reportPublic FDA data

Sleep Aid

Product NDC
49035-736
11-digit product format
490350736
Labeler code
49035
Product ID
49035-736_30ba1ab5-7e1d-439a-843f-f0f0ae3b0362
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
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
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
485ce8ae-c2b7-462f-9c08-8594cd121f0cAvailable 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-736-10Sleep Aid100 in 1 BOTTLE, PLASTICCAPSULE1006
49035-736-32Sleep Aid1 in 1 BOXCAPSULE16
49035-736-32Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-736SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Current NDC, Legacy NDC, 3 package rows20240322_485ce8ae-c2b7-462f-9c08-8594cd121f0c.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 6 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLDiscount Drug Martac1860cb-da95-45bf-9261-19f39c56ddfe2025-12-23WarningsExact identifier
application number: M010
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company468fa756-1ed6-4652-e063-6294a90a67ea2025-12-22WarningsExact identifier
application number: M010
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company468ff5c6-a6eb-b116-e063-6294a90a84e82025-12-22WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLC963c6925-dfbf-4cdc-8d13-5e10b499c4a92025-12-19WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC85391744-3bf5-428e-a77b-464aa95b3a1a2025-12-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b22025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd337a0e6-09ed-4db0-8883-ec8a5d56bd352025-12-11WarningsExact identifier
application number: M010
Topcare ZZZ SleepDIPHENHYDRAMINE HCLTopco Associates LLC27225d04-6deb-436b-89ea-9842c487292e2025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEHEB91426a5b-dc01-a27b-e053-2a95a90a8ff82025-12-09WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life by 7-ElevenDOXYLAMINE SUCCINATE TABLETLil' Drug Store Products, Inc.457814bc-535c-a136-e063-6394a90af9a42025-12-08WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp97eb3e4d-06b7-49ed-909b-95b523dcce412025-12-05WarningsExact identifier
application number: M010
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f50cc038-0973-4c4b-84a7-1c68f41c24102025-12-04WarningsExact identifier
application number: M010
Vicks ZzzQuil Soothing Sleep Nighttime Sleep-AidDIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company0f8a8291-7468-735e-e063-6394a90a66432025-12-02WarningsExact identifier
application number: M010
Walgreens ChildrensNIGHTTIME COUGHWALGREENS CO.a270cbe3-bf0a-44da-9359-00e218eba2392025-12-01WarningsExact identifier
application number: M010
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.141b00b7-a283-40ab-e063-6294a90aec772025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.1f74e760-9ba9-ac47-e063-6394a90acdff2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLDISCOUNT DRUG MART, INC.116e8192-0c2f-39ed-e063-6294a90abaf32025-12-01WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN485ce8ae-c2b7-462f-9c08-8594cd121f0c6
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD485ce8ae-c2b7-462f-9c08-8594cd121f0c6
1020477diphenhydramine HCl 50 MG Oral CapsuleSY485ce8ae-c2b7-462f-9c08-8594cd121f0c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-736-1049035073610100 CAPSULE in 1 BOTTLE, PLASTIC (49035-736-10) 100 capsule2020-01-310000-00-00NoNoCurrent
49035-736-32490350736321 BOTTLE, PLASTIC in 1 BOX (49035-736-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent