NDC 51467-007

COLTALIN-DM

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

COLTALIN-DM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Fortune Pharmacal Company Limited. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID51467-007_330ccd03-1f63-4082-a33b-289064cdb0d1
NDC51467-007
Product TypeHuman Otc Drug
Proprietary NameCOLTALIN-DM
Generic NameAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFORTUNE PHARMACAL COMPANY LIMITED
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51467-007-01

2 BLISTER PACK in 1 BOX (51467-007-01) > 12 TABLET in 1 BLISTER PACK
Marketing Start Date2004-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51467-007-02 [51467000702]

COLTALIN-DM TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-04-26

NDC 51467-007-01 [51467000701]

COLTALIN-DM TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-03-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:8b1138f2-aad0-43ef-80d4-e36f92fe5e93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086991

    • NDC Crossover Matching brand name "COLTALIN-DM" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    51467-007COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    0280-1212Alka-Seltzer Plus Maximum Strength Cold and CoughAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0280-0023Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizzacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1560Alka-Seltzer Plus Severe Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-009Calmadol PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    56062-239childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    63868-374Childrens Multi-Symptom Cold PlusAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0363-0034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    11822-5047Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    15127-931Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    21130-034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    41520-704Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    46122-310Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55315-304Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55910-043Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55910-014DG Health cold multi symptomAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    58552-137Giltuss Childrens MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    58552-136Giltuss MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-001Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    49873-114Stonaacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    49873-113Stona-Sacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    36800-809topcare childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
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