FDA.reportPublic FDA data

Broncolito

Product NDC
55758-520
11-digit product format
557580520
Labeler code
55758
Product ID
55758-520_54ec4c3c-358a-2601-e063-6294a90afcf8
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Pharmadel LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
50; 2.5; 5 mg/2.5mL; mg/2.5mL; mg/2.5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Broncolito
Brand name suffix
Children
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN50 mg/2.5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/2.5mL
DEXTROMETHORPHAN HYDROBROMIDE5 mg/2.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
509f5b72-9894-ef44-e063-6394a90a6d07Available on FDA.report

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 75 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mixed Berry Sore Throat and Cough LozengesBENZOCAINEHEB3063ea93-6bc2-1d18-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
HEB Menthol Cough DropsMENTHOLHEBc197855d-15b4-38fc-e053-2a95a90a2dc72025-12-13WarningsExact identifier
application number: M012
HEB SF Honey Lemon Cough DropsMENTHOLHEBd09ed4bb-7595-5e54-e053-2a95a90aa1092025-12-13WarningsExact identifier
application number: M012
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382025-12-13WarningsExact identifier
application number: M012
HEB Honey Lemon Cough DropsMENTHOLHEBc19a79bc-9872-2e87-e053-2a95a90a94272025-12-13WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.26f55169-4b37-4a36-88ee-064d6e9620652025-12-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company39ce76a3-b7a8-43be-9b61-5c1446cd9e902025-12-12WarningsExact identifier
application number: M012
Cold and Flu maximum strengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationac01206f-a717-4c0b-8a03-fab0a4fd154b2025-12-12WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLStrategic Sourcing Services LLCdcb80dd5-465d-4792-947a-3044e25a52842025-12-12WarningsExact identifier
application number: M012
Vapor RubCOUGH SUPPRESSANTNeilmed Pharmaceuticals Inc.39190f9f-8a5a-e4d8-e063-6294a90a57dd2025-12-12WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Life by 7-ElevenDIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c4cd6c-327d-5950-e063-6394a90a3a212025-12-12WarningsExact identifier
application number: M012
Menthol cough dropsMENTHOLFamily Dollar44bb3b95-b2ba-470e-e054-00144ff88e882025-12-12WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLFamily Dollar44bb9c7b-994b-4ab8-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44be9837-f15a-09f2-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44bcae39-2389-09ee-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar46635813-66c4-504c-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar455b0f4b-0526-2361-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
Family Wellness Strawberry Cough DropsMENTHOLFamily Dollarf92466ac-dd93-9ac5-e053-6294a90a92912025-12-12WarningsExact identifier
application number: M012
GoodSense Menthol Cough DropsMENTHOLGeiss, Destin, Dunnc6b25d69-8930-6867-e053-2a95a90ad2082025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Cough DropsMENTHOLGeiss, Destin, Dunnc72db7f0-9324-8ed2-e053-2995a90a98682025-12-12WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55758-520-08557580520081 BOTTLE, PLASTIC in 1 CARTON (55758-520-08) / 237 mL in 1 BOTTLE, PLASTIC2026-07-01NoNoCurrent