Home NDC 36800-642 Sinus and Allergy Relief PE
Product NDC 36800-642
11-digit product format 368000642
Labeler code 36800
Product ID 36800-642_c1953473-6954-4a2e-810e-e8b73e7f347f
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Topco Associates, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-02
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 4; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Sinus and Allergy Relief PE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090443 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 36800-642-08 Sinus and Allergy Relief PE 24 in 1 BLISTER PACK TABLET 24 6 36800-642-08 Sinus and Allergy Relief PE 1 in 1 CARTON TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-642 SINUS AND ALLERGY RELIEF PE (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOPCO ASSOCIATES, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240724_2a80fba9-5e30-4ec0-bd8e-8957c0654b6c.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 Marketing end Sample Exclude flag Status 36800-642-08 36800064208 1 BLISTER PACK in 1 CARTON (36800-642-08) / 24 TABLET in 1 BLISTER PACK 1 blister pack 2021-07-02 0000-00-00 No No Current