FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
68998-505
11-digit product format
689980505
Labeler code
68998
Product ID
68998-505_4653161c-6665-afeb-e063-6294a90af6bb
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
Marc Glassman, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-02
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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
Childrens Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68998-505-242025-12-19C16284748780-1f386c649-f66f-0266-e053-dadaa90a7c1ae916ef86-ca73-42dd-83dc-6033f56d96f2
68998-505-242023-01-30C16284748780-1f386c649-f66f-0266-e053-dadaa90a7c1ae916ef86-ca73-42dd-83dc-6033f56d96f2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68998-505-24Childrens Allergy Relief118 mL in 1 BOTTLELIQUID1183

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-505CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]2Current NDC, Legacy NDC, 1 package rows20200118_e916ef86-ca73-42dd-83dc-6033f56d96f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNe916ef86-ca73-42dd-83dc-6033f56d96f23
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDe916ef86-ca73-42dd-83dc-6033f56d96f23
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYe916ef86-ca73-42dd-83dc-6033f56d96f23
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYe916ef86-ca73-42dd-83dc-6033f56d96f23
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYe916ef86-ca73-42dd-83dc-6033f56d96f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68998-505-2468998050524118 mL in 1 BOTTLE (68998-505-24) 118 ml2014-12-020000-00-00NoNoCurrent