FDA.reportPublic FDA data

Dye Free Allergy Relief

Product NDC
76162-914
11-digit product format
761620914
Labeler code
76162
Product ID
76162-914_4279e83d-bb78-a1f8-e063-6394a90a0238
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-07
Substance
DIPHENHYDRAMINE HCL
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dye Free Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HCL25 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
6ddf6b16-0ff3-4014-9f73-33e854397fe5Available 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
76162-914-24Dye Free Allergy Relief2 in 1 CARTONCAPSULE, LIQUID FILLED24
76162-914-24Dye Free Allergy Relief12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-914DYE FREE ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES, LLC]2Current NDC, 2 package rows20250409_6ddf6b16-0ff3-4014-9f73-33e854397fe5.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
Dye Free Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLC6ddf6b16-0ff3-4014-9f73-33e854397fe52025-10-31WarningsExact identifier
ndc (product): 76162-914

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN6ddf6b16-0ff3-4014-9f73-33e854397fe54
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD6ddf6b16-0ff3-4014-9f73-33e854397fe54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-914-24761620914242 BLISTER PACK in 1 CARTON (76162-914-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-04-07NoNoCurrent