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 70 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012
CAREALL DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incf3b177ef-55d5-4525-bf33-99205c414a5b2025-12-22WarningsExact identifier
application number: M012
CAREALL Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incaf2f8389-d696-4060-8abd-6eda04e730092025-12-22WarningsExact identifier
application number: M012
BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC82e68c65-9898-4106-a2f8-e39d124c703e2025-12-22WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLWalgreens464f6645-ca33-1722-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalgreen Co.47f38e79-c730-21b9-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLWalgreen Co.47522852-005a-2a66-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreens Co,47653657-80b5-482f-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreen Co.47f89d33-6e0a-4bb4-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Strawberry Cough DropMENTHOL 2.7 MGWalgreen Co.4766afa8-fdaf-05e5-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLWalgreen Co.477b9fc3-c3c5-647e-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropMENTHOLWalgreen Co.477cedee-6bd3-2a34-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEWalgreens Co.47e0f809-0b30-2b23-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalgreen835e276a-493e-1038-e053-2a91aa0a7ea22025-12-21WarningsExact identifier
application number: M012
Walgreens Mixed Berry Benz-Dex LozengesBENZOCAINEWalgreene108731f-6b77-225a-e053-2a95a90ac25c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalmart Stores Inc.318e7acb-0ebb-4518-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWalmart Stores Inc.316968e1-7715-4caa-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon cough dropsMENTHOLWalmart Stores Inc.317bbd33-6087-3af1-e054-00144ff8d46c2025-12-21WarningsExact 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