FDA.reportPublic FDA data

Bactimicina Childrens Cough and Cold

Product NDC
24286-1551
Requested package NDC
24286-1551-4
11-digit product format
242861551
Labeler code
24286
Product ID
24286-1551_3530e736-bec2-97cf-e063-6394a90af401
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DLC Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-23
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1; 7.5 mg/5mL; mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
Bactimicina Childrens Cough and Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal 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
1111440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d407a583-07ae-4d47-b15a-24b5865c82daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24286-1551-4Bactimicina Childrens Cough and Cold1 in 1 BOXLIQUID19
24286-1551-4Bactimicina Childrens Cough and Cold118 mL in 1 BOTTLELIQUID1189

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24286-1551BACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]9Current NDC, Legacy NDC, 2 package rows20250516_d407a583-07ae-4d47-b15a-24b5865c82da.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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSNd407a583-07ae-4d47-b15a-24b5865c82da9
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCDd407a583-07ae-4d47-b15a-24b5865c82da9
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSYd407a583-07ae-4d47-b15a-24b5865c82da9
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSYd407a583-07ae-4d47-b15a-24b5865c82da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24286-1551-4242861551041 BOTTLE in 1 BOX (24286-1551-4) / 118 mL in 1 BOTTLE1 bottle2009-10-230000-00-00NoNoCurrent