Home NDC 53943-113 Allergy
Product NDC 53943-113
11-digit product format 539430113
Labeler code 53943
Product ID 53943-113_24ada091-b461-930f-e063-6394a90a0a3d
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler DISCOUNT DRUG MART
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-11-30
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 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 Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049909 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53943-113-01 Allergy 12 in 1 BLISTER PACK CAPSULE 12 3 53943-113-01 Allergy 2 in 1 CARTON CAPSULE 2 3 53943-113-03 Allergy 1 in 1 CARTON CAPSULE 1 3 53943-113-03 Allergy 100 in 1 BOTTLE, PLASTIC CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-113 ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [DISCOUNT DRUG MART] 3 Current NDC, Legacy NDC, 4 package rows 20241019_4d93a703-c905-4fb3-b772-11c207065d4d.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53943-113-01 53943011301 2 BLISTER PACK in 1 CARTON (53943-113-01) / 12 CAPSULE in 1 BLISTER PACK 2 blister pack 2007-11-30 0000-00-00 No No Current 53943-113-03 53943011303 1 BOTTLE, PLASTIC in 1 CARTON (53943-113-03) / 100 CAPSULE in 1 BOTTLE, PLASTIC 2007-11-30 0000-00-00 No No Current