FDA.reportPublic FDA data

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

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
COLD AND FLU TEA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/13g
CHLORPHENIRAMINE MALEATE4 mg/13g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7d3f54e-59ef-4b85-a88d-b053058dc1f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-097-12BRONCOCHEMCOLD AND FLU TEA25 in 1 BOXGRANULE, FOR SOLUTION2511
65131-097-52BRONCOCHEMCOLD AND FLU TEA13 g in 1 PACKAGEGRANULE, FOR SOLUTION1311
65131-097-53BRONCOCHEMCOLD AND FLU TEA6 in 1 BOXGRANULE, FOR SOLUTION611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
HONEYINACTIVE INGREDIENTY9H1V576FHBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
PHENYLEPHRINE HYDROCHLORIDEINACTIVE INGREDIENT04JA59TNSJBRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
SUCROSEINACTIVE INGREDIENTC151H8M554BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666BRONCOCHEM 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
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-097BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL]11Current NDC, Legacy NDC, 3 package rows20241215_b7d3f54e-59ef-4b85-a88d-b053058dc1f6.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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
ndc (product): 65131-097
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65131-097-126513100971225 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52) 25 package2017-09-280000-00-00NoNoCurrent
65131-097-526513100975213 g in 1 PACKAGE13 gHistorical
65131-097-53651310097536 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52) 6 package2017-09-280000-00-00NoNoCurrent