FDA.reportPublic FDA data

Childrens Allergy

Product NDC
69676-0074
11-digit product format
696760074
Labeler code
69676
Product ID
69676-0074_2ea022ca-e2ee-3856-e063-6294a90a484f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Genexa Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-26
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
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
69676-0074-92025-02-26C16284748780-12cef2736-a29d-d83d-e063-dadaa90ab31fChildren's Allergy
69676-0074-92025-01-30C16284748780-12cef2736-a29d-d83d-e063-dadaa90ab31fChildren's Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0074-9Childrens Allergy1 in 1 CARTONSOLUTION12
69676-0074-9Childrens Allergy118 mL in 1 BOTTLE, PLASTICSOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0074CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [GENEXA INC.]2Current NDC, 2 package rows20250228_e880b8d7-61c3-41cc-e053-2995a90aaaeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNe880b8d7-61c3-41cc-e053-2995a90aaaeb2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDe880b8d7-61c3-41cc-e053-2995a90aaaeb2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYe880b8d7-61c3-41cc-e053-2995a90aaaeb2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYe880b8d7-61c3-41cc-e053-2995a90aaaeb2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYe880b8d7-61c3-41cc-e053-2995a90aaaeb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69676-0074-9696760074091 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9) / 118 mL in 1 BOTTLE, PLASTIC2022-04-26NoNoCurrent