FDA.reportPublic FDA data

Dye Free Allergy

Product NDC
63868-128
11-digit product format
638680128
Labeler code
63868
Product ID
63868-128_2662f169-3db7-4eee-ba26-e5985af1bea6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-29
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
Dye Free Allergy
Brand name suffix
childrens
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
63868-128-042023-04-27C16284748780-1f386c649-c82a-0266-e053-dadaa90a7c1aDrug Facts
63868-128-042023-01-30C16284748780-1f386c649-c82a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-128-04Dye Free Allergychildrens1 in 1 BOXLIQUID16
63868-128-04Dye Free Allergychildrens118 mL in 1 BOTTLE, PLASTICLIQUID1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-128-04ML - Milliliter63868-128e5564ccc-c883-4a9d-bd1f-8afcef5e464b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-128DYE FREE ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 2 package rows20240423_f1a33c2f-2330-43f3-8026-de21808aec66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNf1a33c2f-2330-43f3-8026-de21808aec666
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDf1a33c2f-2330-43f3-8026-de21808aec666
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYf1a33c2f-2330-43f3-8026-de21808aec666
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYf1a33c2f-2330-43f3-8026-de21808aec666
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYf1a33c2f-2330-43f3-8026-de21808aec666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-128-04638680128041 BOTTLE, PLASTIC in 1 BOX (63868-128-04) / 118 mL in 1 BOTTLE, PLASTIC2016-02-290000-00-00NoNoCurrent