NDC 53809-204

DOMETUSS-NR

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl

DOMETUSS-NR is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Domel Laboratories. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID53809-204_7ed60dfb-955e-43be-9e4c-79215ab1c7d1
NDC53809-204
Product TypeHuman Otc Drug
Proprietary NameDOMETUSS-NR
Generic NameAcetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-01-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDomel Laboratories
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53809-204-01

100 TABLET in 1 BOTTLE (53809-204-01)
Marketing Start Date2016-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53809-204-01 [53809020401]

DOMETUSS-NR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-01-21

NDC 53809-204-04 [53809020404]

DOMETUSS-NR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-21

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

NDC Crossover Matching brand name "DOMETUSS-NR" or generic name "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl"

NDCBrand NameGeneric Name
53809-204DOMETUSS-NRACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
53809-240DOMETUSS-NRDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE
0113-2476AllergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
30142-476allergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
37808-476AllergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
50844-455AllergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
55315-456AllergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
67091-210Allergy and Pain ReliefAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
57243-455Allergy Multi SymptomAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
15127-967Allergy Multi-SymptomAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
30142-650Allergy ReliefAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
56062-616allergy sinus PEAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
63654-275Cold MedicineAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
0573-1238DRISTAN COLD MULTISYMPTOMacetaminophen, chlorpheniramine maleate, phenylephrine HCl
0135-0578FLONASEacetaminophen, chlorpheniramine maleate, phenylephrine hcl
0113-0476Good Sense Allergy Multi SymptomAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
0363-0559Multi-Symptom AllergyAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
0363-4554Sinus Congestion and PainAcetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
15127-933Sinus Congestion and PainAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
15127-966Sinus Congestion and PainAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
59779-779SINUS PAIN AND CONGESTIONAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
36800-476Topcare Allergy Multi SymptomAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
36800-935Topcare Sinus Congestion and PainAcetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
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