Home NDC 65131-097 BRONCOCHEM
Product NDC 65131-097
11-digit product format 651310097
Labeler code 65131
Product ID 65131-097_54539b4d-eb99-4198-8486-bfac15605c04
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application M
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-09-01
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength 500; 4 mg/13g; mg/13g
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 Additional Listing Data#
Finished product Yes
Brand name base BRONCOCHEM
Brand name suffix COLD AND FLU TEA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/13g CHLORPHENIRAMINE MALEATE 4 mg/13g
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, V1Q0O9OJ9Z
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65131-097-12 BRONCOCHEMCOLD AND FLU TEA 25 in 1 BOX GRANULE, FOR SOLUTION 25 11 65131-097-52 BRONCOCHEMCOLD AND FLU TEA 13 g in 1 PACKAGE GRANULE, FOR SOLUTION 13 11 65131-097-53 BRONCOCHEMCOLD AND FLU TEA 6 in 1 BOX GRANULE, FOR SOLUTION 6 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 HONEY INACTIVE INGREDIENT Y9H1V576FH BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 PHENYLEPHRINE HYDROCHLORIDE INACTIVE INGREDIENT 04JA59TNSJ BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1 TRICALCIUM PHOSPHATE INACTIVE INGREDIENT K4C08XP666 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65131-097 BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] 11 Current NDC, Legacy NDC, 3 package rows 20241215_b7d3f54e-59ef-4b85-a88d-b053058dc1f6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65131-097-12 65131009712 25 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52) 25 package 2017-09-28 0000-00-00 No No Current 65131-097-52 65131009752 13 g in 1 PACKAGE 13 g Historical 65131-097-53 65131009753 6 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52) 6 package 2017-09-28 0000-00-00 No No Current