FDA.reportPublic FDA data

Cough and Runny Nose

Product NDC
36800-297
11-digit product format
368000297
Labeler code
36800
Product ID
36800-297_5fc6d0d3-14f3-40f7-a903-f81a91ac9244
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
Dosage form
SUSPENSION
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-31
Marketing end
2027-06-01
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
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
Cough and Runny Nose
Brand name suffix
Childrens Plus

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
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
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
6f04bd51-093c-4624-aef3-0145ac387386Available 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
36800-297-04Cough and Runny NoseChildrens Plus118 mL in 1 BOTTLE, PLASTICSUSPENSION1188
36800-297-04Cough and Runny NoseChildrens Plus1 in 1 BOXSUSPENSION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-297COUGH AND RUNNY NOSE CHILDRENS PLUS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]8Current NDC, Legacy NDC, 2 package rows20240619_6f04bd51-093c-4624-aef3-0145ac387386.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 72 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart6fa4f913-de83-4175-9dad-0dedab5b69a12025-12-19WarningsExact identifier
application number: M012
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf17385bc-82bb-4183-a4c9-067d8afb37572025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Mart9654fdcd-d660-471f-bc5d-aa7dead7a4a82025-12-19WarningsExact identifier
application number: M012
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC621ba20e-75c5-42fb-9692-7800f764c9782025-12-19WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2025-12-19WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
application number: M012
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc3b9b8-e61e-1041-e053-2a91aa0a3d832025-12-18WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-297-04368000297041 BOTTLE, PLASTIC in 1 BOX (36800-297-04) / 118 mL in 1 BOTTLE, PLASTIC2015-12-312027-06-01NoNoCurrent