FDA.reportPublic FDA data

childrens cold and cough

Product NDC
0904-7531
11-digit product format
009047531
Labeler code
0904
Product ID
0904-7531_b0d700aa-e478-46f1-b0fa-6040d78305a3
Type
HUMAN OTC DRUG
Nonproprietary name
brompheniramine maleate, dextromethorphan hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-10
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 10 mg/10mL; mg/10mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
childrens cold and cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7531-20childrens cold and cough1 in 1 CARTONSOLUTION12
0904-7531-20childrens cold and cough118 mL in 1 BOTTLESOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7531-20ML - Milliliter0904-75313ee636f9-660a-4d51-b329-f5d55e9ff83e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7531CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20250315_614880db-478f-468a-8aa2-5ea483cbcfcd.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 117 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN614880db-478f-468a-8aa2-5ea483cbcfcd2
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD614880db-478f-468a-8aa2-5ea483cbcfcd2
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY614880db-478f-468a-8aa2-5ea483cbcfcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7531-20009047531201 BOTTLE in 1 CARTON (0904-7531-20) / 118 mL in 1 BOTTLE1 bottle2025-03-10NoNoCurrent