FDA.reportPublic FDA data

REVASOL SLEEP AID

Product NDC
84379-284
11-digit product format
843790284
Labeler code
84379
Product ID
84379-284_30131010-be71-c940-e063-6394a90a190a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Rnv LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
DIPHENHYDRAMINE HCL
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

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
REVASOL SLEEP AID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HCL50 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
30131010-be70-c940-e063-6394a90a190aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
84379-284-04REVASOL SLEEP AID118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84379-284REVASOL SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [RNV LLC]1Current NDC, 1 package rows20250321_30131010-be70-c940-e063-6394a90a190a.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 SolutionPSN30131010-be70-c940-e063-6394a90a190a1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD30131010-be70-c940-e063-6394a90a190a1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY30131010-be70-c940-e063-6394a90a190a1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY30131010-be70-c940-e063-6394a90a190a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84379-284-0484379028404118 mL in 1 BOTTLE (84379-284-04) 118 ml2025-02-03NoNoCurrent