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 150 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA27ab3d86-e960-4d83-aad1-d50d2c8e02a92024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LavenderCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare2472ce85-c701-4fcd-e063-6394a90a27652024-10-14WarningsExact identifier
application number: M012
HealthWise Chest Rub LemonCAMPHOR, MENTHOL, EUCALYPTUS OILVeridian Healthcare24740d5a-aba1-0bd4-e063-6394a90ab2ca2024-10-14WarningsExact identifier
application number: M012
Childrens Plus Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd432024-10-14WarningsExact identifier
application number: M012
Theraflu Severe Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESINHaleon US Holdings LLCb01cc9f5-53f2-40d8-acf1-6de180b3d0bf2024-10-14WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f5c57b32-69cb-469e-ad2d-64c00b5e66dc2024-10-14WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLPublix Super Markets Inc94c21df5-c631-4748-a833-288b2298055c2024-10-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association8eab9d79-69c1-44b8-9145-a7ebd887d54d2024-10-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Associatione4963eec-fb4a-425c-be19-f514b4f10a7f2024-10-11WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1b4e87f8-3f9e-4865-9128-527d2d6215932024-10-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCff433512-55b7-4fc9-8a55-aff5cbb749ef2024-10-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3170354a-4752-49a0-97ed-3d9db266a0592024-10-11WarningsExact identifier
application number: M012
Tukol Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA235a6d2b-7302-410c-be35-4d5ff7bbdfce2024-10-11WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy6c7b0ea6-bff9-4fd2-9e00-64015c326ee82024-10-11WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Incdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b2024-10-11WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDESafeway838d2f11-2ee4-4081-98c8-b87e79aa47c42024-10-11WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d4def70-480f-f2fa-e053-2995a90a98772024-10-10WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d5b4ef6-4eb8-41f6-e053-2a95a90a13502024-10-10WarningsExact identifier
application number: M012
Tukol Sugar Free Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINGenomma Lab USA95e0a3eb-5a58-4c8b-a70b-fb0cca1e08412024-10-08WarningsExact identifier
application number: M012
Rompe Pecho CF CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06e96e0c-f21f-e706-e063-6294a90a07802024-10-08WarningsExact 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