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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adult Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY586310f3-0014-4cfc-9d86-961b3fb7aa8c2025-11-25WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin

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