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_0591a53d-6cec-439d-8954-9f36de1ef7c7
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
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
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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLEDAMZ789 LLC12dd2419-b2e0-5466-e063-6394a90a42212026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE 50mgDIPHENHYDRAMINE HYDROCHLORIDE 50MGAMZ789 LLCaf0b1b08-e269-6399-e053-2a95a90ac12d2026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.3b1ea33b-8460-31cf-e063-6394a90a55342025-12-31WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLCc1dab616-c3ff-4d0a-be13-e8dc6b1a26cc2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa9678fed-bda5-9513-e053-2995a90a25a12025-12-29WarningsExact identifier
application number: M010
sleep patchesSLEEP PATCHESChangsha Maocheng Trading Co., Ltd25eddec9-1713-c2c8-e063-6394a90af02c2025-12-29WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLC9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.65d1a199-0a8e-41b1-a767-f16e3f91ac942025-12-26WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.837ddc3a-a8d4-454f-974c-979732cb0a222025-12-26WarningsExact identifier
application number: M010
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
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

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