Home NDC 70000-0160 Allergy Relief
Product NDC 70000-0160
11-digit product format 700000160
Labeler code 70000
Product ID 70000-0160_cad6c859-0a91-4d1a-be53-1b702ec8efce
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 110, LLC. DBA Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-12-19
Substance CHLORPHENIRAMINE MALEATE
Active strength 4 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 70000-0160 70000-0160-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70000-0160 70000-0160-1 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 Allergy Relief
Brand name suffix 4 Hour
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1363309 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 70000-0160-1 Allergy Relief4 Hour 2 in 1 CARTON TABLET 2 15 70000-0160-1 Allergy Relief4 Hour 12 in 1 BLISTER PACK TABLET 12 15 70000-0160-2 Allergy Relief4 Hour 1 in 1 CARTON TABLET 1 15 70000-0160-2 Allergy Relief4 Hour 100 in 1 BOTTLE TABLET 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0160 ALLERGY RELIEF 4 HOUR (CHLORPHENIRAMINE MALEATE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER] 13 Current NDC, Legacy NDC, 4 package rows 20240702_aaecfda5-1a50-4d8a-9909-7153c1a22bda.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 · 3,550 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 70000-0160-1 70000016001 2 BLISTER PACK in 1 CARTON (70000-0160-1) > 12 TABLET in 1 BLISTER PACK 2 blister pack 1992-12-19 0000-00-00 No No Current 70000-0160-2 70000016002 1 BOTTLE in 1 CARTON (70000-0160-2) / 100 TABLET in 1 BOTTLE 1 bottle 1992-12-19 0000-00-00 No No Current