FDA.reportPublic FDA data

Sleep Aid

Product NDC
49580-0314
11-digit product format
495800314
Labeler code
49580
Product ID
49580-0314_13e7d3b7-fe21-44d9-91cb-d21f051443d0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-31
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
2026-12-31
Current FDA listing
Yes

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 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
4144b1a6-aeae-4560-a997-b07206d80350Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0314-2Sleep AidNightTime355 mL in 1 BOTTLE, PLASTICLIQUID3558
49580-0314-4Sleep AidNightTime118 mL in 1 BOTTLE, PLASTICLIQUID1188
49580-0314-6Sleep AidNightTime177 mL in 1 BOTTLE, PLASTICLIQUID1778

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0314SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [P & L DEVELOPMENT, LLC]8Current NDC, Legacy NDC, 3 package rows20250326_4144b1a6-aeae-4560-a997-b07206d80350.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 · 261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
application number: M010
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
application number: M010
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
application number: M010
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
application number: M010
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
application number: M010
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLDOLGENCORP, LLC2bb3016a-2e03-43fe-a655-45d4ec872c792026-08-05WarningsExact identifier
application number: M010
Nighttime Sleep Aid Alcohol FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc6e398d21-6cfa-4f9b-9219-0cd949e882662026-08-05WarningsExact identifier
application number: M010
Sleep TabsDIPHENHYDRAMINE HCLMajor Pharmaceuticalsff8b7346-5be5-4e76-9ee2-d52fab66f6c52026-08-03WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-07-27WarningsExact identifier
application number: M010
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN4144b1a6-aeae-4560-a997-b07206d803508
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD4144b1a6-aeae-4560-a997-b07206d803508
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY4144b1a6-aeae-4560-a997-b07206d803508
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY4144b1a6-aeae-4560-a997-b07206d803508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0314-249580031402355 mL in 1 BOTTLE, PLASTIC (49580-0314-2) 355 ml2016-08-310000-00-00NoNoCurrent
49580-0314-449580031404118 mL in 1 BOTTLE, PLASTIC (49580-0314-4) 118 ml2016-08-31NoNoCurrent
49580-0314-649580031406177 mL in 1 BOTTLE, PLASTIC (49580-0314-6) 177 ml2016-08-310000-00-00NoNoCurrent