FDA.reportPublic FDA data

CVS Health Nighttime Sleep-Aid

Product NDC
59779-893
11-digit product format
597790893
Labeler code
59779
Product ID
59779-893_4584fc13-e4b4-e768-e063-6394a90aaf22
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy,Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-22
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
CVS Health Nighttime 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
a575a914-14a0-442c-a504-ac7a0aa0ac77Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-893-06CVS Health Nighttime Sleep-Aid177 mL in 1 BOTTLE, PLASTICLIQUID1779
59779-893-12CVS Health Nighttime Sleep-Aid354 mL in 1 BOTTLE, PLASTICLIQUID3549
59779-893-24CVS Health Nighttime Sleep-Aid354 mL in 1 BOTTLELIQUID3548
59779-893-24CVS Health Nighttime Sleep-Aid2 in 1 PACKAGE, COMBINATIONLIQUID28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-893CVS HEALTH NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]8Current NDC, Legacy NDC, 1 package rows20240822_a575a914-14a0-442c-a504-ac7a0aa0ac77.zip
59779-893CVS HEALTH NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]8Current NDC, Legacy NDC, 1 package rows20240822_9f944edc-a317-4967-ae54-67b5d183591b.zip
59779-893CVS HEALTH NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]7Current NDC, Legacy NDC, 2 package rows20240822_e8785ba8-e53e-491e-bbfe-04e860f36131.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
ndc (product): 59779-893
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
ndc (product): 59779-893
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
ndc (product): 59779-893
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 SolutionPSN9f944edc-a317-4967-ae54-67b5d183591b9
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNa575a914-14a0-442c-a504-ac7a0aa0ac779
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD9f944edc-a317-4967-ae54-67b5d183591b9
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDa575a914-14a0-442c-a504-ac7a0aa0ac779
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY9f944edc-a317-4967-ae54-67b5d183591b9
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYa575a914-14a0-442c-a504-ac7a0aa0ac779
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY9f944edc-a317-4967-ae54-67b5d183591b9
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYa575a914-14a0-442c-a504-ac7a0aa0ac779
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNe8785ba8-e53e-491e-bbfe-04e860f361318
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDe8785ba8-e53e-491e-bbfe-04e860f361318
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYe8785ba8-e53e-491e-bbfe-04e860f361318
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYe8785ba8-e53e-491e-bbfe-04e860f361318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-893-0659779089306177 mL in 1 BOTTLE, PLASTIC (59779-893-06) 177 ml2015-09-220000-00-00NoNoCurrent
59779-893-1259779089312354 mL in 1 BOTTLE, PLASTIC (59779-893-12) 354 ml2015-02-110000-00-00NoNoCurrent
59779-893-24597790893242 BOTTLE in 1 PACKAGE, COMBINATION (59779-893-24) / 354 mL in 1 BOTTLE2 bottle2016-07-140000-00-00NoNoCurrent