FDA.reportPublic FDA data

Free and Pure Allergy Relief

Product NDC
0363-1175
11-digit product format
003631175
Labeler code
0363
Product ID
0363-1175_4279aaad-dde8-08be-e063-6394a90ad40b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREEN COMPANY
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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
Free and Pure Allergy Relief
Brand name suffix
Dye Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93182db8-05bc-4eb5-aa14-cef58de25359Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1175-24Free and Pure Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
0363-1175-24Free and Pure Allergy ReliefDye Free2 in 1 CARTONCAPSULE, LIQUID FILLED24
0363-1175-48Free and Pure Allergy ReliefDye Free4 in 1 CARTONCAPSULE, LIQUID FILLED44
0363-1175-48Free and Pure Allergy ReliefDye Free12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1175FREE AND PURE ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]3Current NDC, 4 package rows20241208_93182db8-05bc-4eb5-aa14-cef58de25359.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Free and Pure Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREEN COMPANY93182db8-05bc-4eb5-aa14-cef58de253592025-10-31WarningsExact identifier
ndc (product): 0363-1175

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN93182db8-05bc-4eb5-aa14-cef58de253594
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD93182db8-05bc-4eb5-aa14-cef58de253594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1175-24003631175242 BLISTER PACK in 1 CARTON (0363-1175-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2023-10-22NoNoCurrent
0363-1175-48003631175484 BLISTER PACK in 1 CARTON (0363-1175-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2023-10-22NoNoCurrent