Home NDC 70000-0652 Cold Relief
Product NDC 70000-0652
11-digit product format 700000652
Labeler code 70000
Product ID 70000-0652_1d54aca1-9fae-4c59-943f-9c76996bd28f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 110, LLC. DBA Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-25
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Cold Relief
Brand name suffix Multi-Symptom
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0652-1 Cold ReliefMulti-Symptom 2 in 1 CARTON TABLET, FILM COATED 2 3 70000-0652-1 Cold ReliefMulti-Symptom 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0652 COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER] 2 Current NDC, 2 package rows 20241017_0c94780d-e901-43fc-ad8a-80c5d61ea47b.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70000-0652-1 70000065201 2 BLISTER PACK in 1 CARTON (70000-0652-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2023-10-25 No No Current