Home NDC 70000-0474 leader childrens allergy relief
Product NDC 70000-0474
11-digit product format 700000474
Labeler code 70000
Product ID 70000-0474_8166578a-7f50-40f6-b681-c965f72288ba
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-04
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70000-0474 70000-0474-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70000-0474 70000-0474-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 leader childrens allergy relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 1049906 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0474-1 leader childrens allergy relief 1 in 1 CARTON SOLUTION 1 5 70000-0474-1 leader childrens allergy relief 118 mL in 1 BOTTLE SOLUTION 118 5 70000-0474-2 leader childrens allergy relief 1 in 1 CARTON SOLUTION 1 5 70000-0474-2 leader childrens allergy relief 237 mL in 1 BOTTLE SOLUTION 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0474 LEADER CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] 4 Current NDC, Legacy NDC, 4 package rows 20240710_40d697b7-dc59-4d24-8d46-db635e01b9d5.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 70000-0474-1 70000047401 1 BOTTLE in 1 CARTON (70000-0474-1) / 118 mL in 1 BOTTLE 1 bottle 2020-01-03 0000-00-00 No No Current 70000-0474-2 70000047402 1 BOTTLE in 1 CARTON (70000-0474-2) > 237 mL in 1 BOTTLE 1 bottle 2019-12-04 0000-00-00 No No Current