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

Related Records

Packages

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 pack2025-04-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dye Free Allergy ReliefTopco Associates, LLC2025-10-31HUMAN OTC DRUG LABEL4
Dye Free Allergy ReliefTopco Associates, LLC2025-06-09HUMAN OTC DRUG LABEL3