NDC 51467-008

COLTALIN-ND

Acetaminophen, Phenylephrine Hydrochloride

COLTALIN-ND 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; Phenylephrine Hydrochloride.

Product ID51467-008_41d2cd7a-e027-40cd-a111-c633c76f2e82
NDC51467-008
Product TypeHuman Otc Drug
Proprietary NameCOLTALIN-ND
Generic NameAcetaminophen, 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; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51467-008-01

2 BLISTER PACK in 1 BOX (51467-008-01) > 12 TABLET in 1 BLISTER PACK
Marketing Start Date2004-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51467-008-02 [51467000802]

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

NDC 51467-008-01 [51467000801]

COLTALIN-ND 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:28f41696-7d67-436e-aa33-86d8ba82efd7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046378
  • 1540520

    • NDC Crossover Matching brand name "COLTALIN-ND" or generic name "Acetaminophen, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    51467-008COLTALIN-NDCOLTALIN-ND
    46084-101ACETAMINOPHEN SINUS CONGESTION AND PAINACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-001Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-002Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-158Medi First Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-146Medi First Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-148Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-509Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    37808-466Sinus Congestion and PainAcetaminophen, Phenylephrine Hydrochloride
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