FDA.reportPublic FDA data

InstaRelief Nighttime Sleep Aid

Product NDC
71598-120
11-digit product format
715980120
Labeler code
71598
Product ID
71598-120_4081a49d-9a39-2867-e063-6294a90ac822
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DXM Pharmacuetical, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/3mL
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
InstaRelief Nighttime Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui2671699

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71598-120-19InstaRelief Nighttime Sleep Aid1 in 1 CARTONLIQUID13
71598-120-19InstaRelief Nighttime Sleep Aid120 mL in 1 BOTTLELIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71598-120INSTARELIEF NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DXM PHARMACUETICAL, INC.]2Current NDC, 2 package rows20241009_e0459e71-32dd-4715-b103-bb14db42c5f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671699diphenhydrAMINE HCl 50 MG in 3 mL Oral SolutionPSNe0459e71-32dd-4715-b103-bb14db42c5f33
2671699diphenhydramine hydrochloride 16.7 MG/ML Oral SolutionSCDe0459e71-32dd-4715-b103-bb14db42c5f33
2671699diphenhydramine HCl 50 MG per 3 ML Oral SolutionSYe0459e71-32dd-4715-b103-bb14db42c5f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71598-120-19715980120191 BOTTLE in 1 CARTON (71598-120-19) / 120 mL in 1 BOTTLE1 bottle2023-10-01NoNoHistorical