FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
55315-003
11-digit product format
553150003
Labeler code
55315
Product ID
55315-003_469b51ca-4778-4366-8e00-6805fcb1469b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
fred's, Inc.
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-23
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-003-122019-11-27C16284748780-19855e2a2-4035-60a7-e053-dbdaa90a05bdNighttime Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-003-12Nighttime Sleep Aid177 mL in 1 BOTTLE, PLASTICLIQUID1771

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-003NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FRED'S, INC.]1Legacy NDC, 1 package rows20140103_5089fd55-d51b-4bc9-aa05-cbc175c40e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN5089fd55-d51b-4bc9-aa05-cbc175c40e041
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD5089fd55-d51b-4bc9-aa05-cbc175c40e041
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY5089fd55-d51b-4bc9-aa05-cbc175c40e041
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY5089fd55-d51b-4bc9-aa05-cbc175c40e041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55315-003-1255315000312177 mL in 1 BOTTLE, PLASTIC177 mlHistorical