NDC 0573-2840

PREPARATION H COOLING Gel

Phenylephrine Hcl, Witch Hazel

PREPARATION H COOLING Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Phenylephrine Hydrochloride; Witch Hazel.

Product ID0573-2840_16333112-f953-452b-a508-05ff756e9933
NDC0573-2840
Product TypeHuman Otc Drug
Proprietary NamePREPARATION H COOLING Gel
Generic NamePhenylephrine Hcl, Witch Hazel
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2004-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active Ingredient Strength3 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0573-2840-10

1 TUBE in 1 CARTON (0573-2840-10) > 26 g in 1 TUBE
Marketing Start Date2004-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0573-2840-20 [00573284020]

PREPARATION H COOLING Gel GEL
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2004-01-01

NDC 0573-2840-10 [00573284010]

PREPARATION H COOLING Gel GEL
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2004-01-01

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

OpenFDA Data

SPL SET ID:cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905037
  • 249465
  • NDC Crossover Matching brand name "PREPARATION H COOLING Gel" or generic name "Phenylephrine Hcl, Witch Hazel"

    NDCBrand NameGeneric Name
    0573-2840PREPARATION H COOLING Gelphenylephrine HCl, witch hazel
    43749-450Avedana HEMORRHOIDAL COOLING GelPhenylephrine HCl, Witch Hazel
    59779-843coolingPhenylephrine HCl, Witch hazel
    80489-959Drs. pharmacy HEMORRHOIDAL COOLINGphenylephrine HCL, witch hazel
    41163-843Equaline hemorrhoidal coolingPhenylephrine HCl, Witch hazel
    0363-0086Hemorrhoidal coolingPhenylephrine HCl, Witch hazel
    0363-0843Hemorrhoidal CoolingPhenylephrine HCl, Witch hazel
    70648-009OLP HEMORRHOIDAL COOLINGphenylephrine HCL, witch hazel

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