FDA.reportPublic FDA data

TOPCARE

Product NDC
76162-792
11-digit product format
761620792
Labeler code
76162
Product ID
76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-12
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
160; 1; 5 mg/5mL; 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

Additional Listing Data#

Finished product
Yes
Brand name base
TOPCARE
Brand name suffix
Childrens Cold and Cough and Runny Nose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL
CHLORPHENIRAMINE MALEATE1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH
Rxcui1086750

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-792-04TOPCAREChildrens Cold and Cough and Runny Nose120 mL in 1 BOTTLESUSPENSION1202
76162-792-04TOPCAREChildrens Cold and Cough and Runny Nose1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-792TOPCARE CHILDRENS COLD AND COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [TOPCO ASSOCIATES, LLC]1Current NDC, 2 package rows20240901_8931d4ca-c599-49be-87e1-8c0598f38b77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086750acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral SuspensionPSN8931d4ca-c599-49be-87e1-8c0598f38b772
1086750acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSCD8931d4ca-c599-49be-87e1-8c0598f38b772
1086750acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral SuspensionSY8931d4ca-c599-49be-87e1-8c0598f38b772
1086750APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SuspensionSY8931d4ca-c599-49be-87e1-8c0598f38b772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-792-04761620792041 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLE1 bottle2024-08-12NoNoCurrent