FDA.reportPublic FDA data

EZ Nite Sleep

Product NDC
21130-014
11-digit product format
211300014
Labeler code
21130
Product ID
21130-014_4d80361e-4854-47ec-b9bc-a09209e4f53d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
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
EZ Nite Sleep
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
21a68c60-3005-43bb-8ec5-7982239c93f8Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
21130-014-06EZ Nite Sleep177 mL in 1 BOTTLE, PLASTICLIQUID17710
21130-014-12EZ Nite Sleep355 mL in 1 BOTTLE, PLASTICLIQUID35510
21130-014-24EZ Nite Sleep355 mL in 1 BOTTLE, PLASTICLIQUID35510
21130-014-24EZ Nite Sleep2 in 1 PACKAGE, COMBINATIONLIQUID210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KEZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-014EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]9Current NDC, Legacy NDC, 4 package rows20240925_21a68c60-3005-43bb-8ec5-7982239c93f8.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 138 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012
Equate Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalmart6271bb48-74b2-eb57-e053-2991aa0afd1b2024-11-13WarningsExact identifier
application number: M012
Equaline Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEUnited Natural Foods, Inc. dba UNFI6bf341e0-94b1-08ff-e053-2991aa0af6342024-11-13WarningsExact identifier
application number: M012
Good Sense Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEGood Sensecd25e250-bb8b-7e83-e053-2a95a90a26392024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd440a00b1-7960-0cc4-e054-00144ff8d46c2024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd.c6f207e8-bc0d-853a-e053-2a95a90ac6232024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDOLGENCORP, LLC7fad8e65-34fe-5313-e053-2a91aa0a56f42024-11-13WarningsExact identifier
application number: M012
Dollar General Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATEDOLGENCORP, LLC7face5c7-f5c7-7eee-e053-2991aa0ab0642024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEChain Drug Marketing Association90622927-9682-4eb0-8c7f-894230b3dda42024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca2024-11-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN21a68c60-3005-43bb-8ec5-7982239c93f810
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD21a68c60-3005-43bb-8ec5-7982239c93f810
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY21a68c60-3005-43bb-8ec5-7982239c93f810
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY21a68c60-3005-43bb-8ec5-7982239c93f810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-014-0621130001406177 mL in 1 BOTTLE, PLASTIC (21130-014-06) 177 ml2015-06-300000-00-00NoNoCurrent
21130-014-1221130001412355 mL in 1 BOTTLE, PLASTIC (21130-014-12) 355 ml2015-06-300000-00-00NoNoCurrent
21130-014-24211300014242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (21130-014-24) / 355 mL in 1 BOTTLE, PLASTIC2015-06-300000-00-00NoNoCurrent