FDA.reportPublic FDA data

Adult Allergy Relief

Product NDC
0363-7100
11-digit product format
003637100
Labeler code
0363
Product ID
0363-7100_446b2946-7192-592c-e063-6394a90aa1e6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
WALGREEN COMPANY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
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
Adult Allergy Relief
Brand name suffix
Dye Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7100-04Adult Allergy ReliefDye Free1 in 1 CARTONSOLUTION16
0363-7100-04Adult Allergy ReliefDye Free118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7100-04ML - Milliliter0363-7100c0566c11-6469-4fc6-b361-b0efb93f5ef712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7100ADULT ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WALGREEN COMPANY]5Current NDC, Legacy NDC, 2 package rows20241113_586310f3-0014-4cfc-9d86-961b3fb7aa8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN586310f3-0014-4cfc-9d86-961b3fb7aa8c6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD586310f3-0014-4cfc-9d86-961b3fb7aa8c6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY586310f3-0014-4cfc-9d86-961b3fb7aa8c6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY586310f3-0014-4cfc-9d86-961b3fb7aa8c6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY586310f3-0014-4cfc-9d86-961b3fb7aa8c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-7100-04003637100041 BOTTLE in 1 CARTON (0363-7100-04) / 118 mL in 1 BOTTLE1 bottle2020-01-300000-00-00NoNoCurrent