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
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength
1; 5; 160 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

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086750Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8931d4ca-c599-49be-87e1-8c0598f38b77Available 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
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

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 157 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal 12 hourOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Ince9ee03db-a070-4c2b-ac61-7fd22bab27952024-08-31WarningsExact identifier
application number: M012
dg health nasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC42b58928-e8e5-49e4-b49e-498d77d64fcd2024-08-28WarningsExact identifier
application number: M012
nasal mistOXYMETAZOLINE HCLCVS Pharmacyb71c557a-eb93-40d1-87c4-847f5468fc1e2024-08-28WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLKroger Company0a24d98a-5950-49de-8b77-ea880b08d2c52024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLC96e018e2-e0b5-4802-a4a1-73a73d5740822024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HCLTopco Associates LLCb5434599-5485-4949-9d76-b1ef3ad17c1a2024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCb15eb271-7842-495b-aa0f-9b20def86dc12024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf1dd78e0-f700-4469-85d6-18cc299e87462024-08-28WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HCLUnited Natural Foods, Inc. dba UNFI69308693-a094-42a9-a041-e73647a25cc12024-08-27WarningsExact identifier
application number: M012
signature care nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf9ac80d1-3753-412b-a407-18a6b50e5d1c2024-08-27WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.20ac6010-84f4-eeff-e063-6294a90a50a72024-08-27WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HCLArmy & Air Force Exchange Service40d2090d-c332-4dcb-9f43-5ee467e7b3d12024-08-27WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HCLSafeway23f0a5b3-59ae-4eb3-9b7d-e6a4920603372024-08-27WarningsExact identifier
application number: M012
DG Health NasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCdebcda99-c605-4941-b873-9e4dbae274832024-08-27WarningsExact identifier
application number: M012
Good Neighbor Pharmacy NasalOXYMETAZOLINE HCLAmerisource Bergend374d697-2b57-4558-a20b-d3d89aea82d72024-08-27WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLMeijer Distribution Inc3984cbc3-b60c-40a7-bc3a-7d1f600503ac2024-08-27WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLCe6e51821-03ae-4ec3-82a9-b4a8feacd9962024-08-27WarningsExact identifier
application number: M012
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
application number: M012
basic care nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCa154e500-2b45-4242-a26c-9530849f99df2024-08-23WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0c0cf76f-2dd3-45ef-e063-6394a90a9fef2024-08-22WarningsExact identifier
application number: M012

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