Home NDC 65131-054 BRONCOCHEM
Product NDC 65131-054
11-digit product format 651310054
Labeler code 65131
Product ID 65131-054_7ec85034-cc70-4465-bc25-9c700731eb02
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2017-05-01
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength 325; 5; 200 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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 BRONCOCHEM
Brand name suffix KIDS COLD AND FLU
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 04JA59TNSJ Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116568 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 65131-054-18 BRONCOCHEMKIDS COLD AND FLU 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 1 65131-054-18 BRONCOCHEMKIDS COLD AND FLU 1 in 1 BOX SYRUP 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-054 BRONCOCHEM KIDS COLD AND FLU (ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 Current NDC, Legacy NDC, 2 package rows 20170501_523561fb-f6a7-4cde-9be2-bba02e60e208.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65131-054-18 65131005418 1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) / 120 mL in 1 BOTTLE, PLASTIC 2017-05-01 0000-00-00 No No Current