FDA.reportPublic FDA data

Rompe Pecho CF

Product NDC
65852-013
11-digit product format
658520013
Labeler code
65852
Product ID
65852-013_401a97af-36af-4e54-e063-6294a90ab3ee
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate, Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Dextrum Laboratories, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4; 10 mg/5mL; mg/5mL
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
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
Rompe Pecho CF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE4 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal 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
2676758Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
401a97af-36ae-4e54-e063-6294a90ab3eeAvailable on FDA.report

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
65852-013-06Rompe Pecho CF178 mL in 1 BOTTLE, PLASTICLIQUID1781
65852-013-06Rompe Pecho CF1 in 1 CARTONLIQUID11

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 120 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efc46c9-a421-1998-e063-6394a90aeb642025-02-25WarningsExact identifier
application number: M012
Redicare Cough Drops Cherry FlavoredCHERRY FLAVORED MENTHOL COUGH DROPSRedicare LLC2efeaafa-ee96-37ee-e063-6394a90a9a4b2025-02-25WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC77a2dc96-73ee-4ca2-b1fe-4069958026062025-02-19WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEBayer HealthCare LLC.763a5334-a741-4678-9947-6037766224502025-02-18WarningsExact identifier
application number: M012
Sof Skin Vaporizing Chest Rub and Cough SuppressantMENTHOL AND CAMPHOR AND EUCALYPTUS OILViny Health and Beauty Inc46ae16a4-b8a7-44de-ae1a-9bb503c15ea02025-02-18WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
application number: M012
meijer EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bee7e4f-1813-1bdf-e063-6294a90a6a322025-02-17WarningsExact identifier
application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCLKroger Companya24f09d9-60f1-853a-e053-2a95a90ae1fa2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFAMILY DOLLAR SERVICESa7343bea-53cc-4621-e053-2a95a90a2a5f2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8f6dd0-d19f-0c10-e053-2a95a90a1e8a2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8ebccf-6813-2dca-e053-2a95a90a032b2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFAMILY DOLLARaa8f0465-1595-0b0f-e053-2a95a90a00812025-02-15WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH-E-Bdb432947-fe02-79b2-e053-2a95a90af4a92025-02-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG in 5 mL Oral SolutionPSN401a97af-36ae-4e54-e063-6294a90ab3ee1
2676758brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral SolutionSCD401a97af-36ae-4e54-e063-6294a90ab3ee1
2676758brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG per 5 ML Oral SolutionSY401a97af-36ae-4e54-e063-6294a90ab3ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-013-06658520013061 BOTTLE, PLASTIC in 1 CARTON (65852-013-06) / 178 mL in 1 BOTTLE, PLASTIC2023-10-01NoNoCurrent