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    NDC 00573-2840-10 Preparation H Cooling Gel 2.5; 500 mg/g; mg/g Details

    Preparation H Cooling Gel 2.5; 500 mg/g; mg/g

    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 Information

    NDC 00573-2840
    Product ID 0573-2840_3e24784a-7d44-43a0-ac39-55bd22f09c5b
    Associated GPIs 89994002374020
    GCN Sequence Number 048136
    GCN Sequence Number Description phenylephrine HCl/witch hazel GEL (GRAM) 0.25%-50% TOPICAL
    HIC3 Q3D
    HIC3 Description HEMORRHOIDAL PREPARATIONS
    GCN 13569
    HICL Sequence Number 022735
    HICL Sequence Number Description PHENYLEPHRINE HCL/WITCH HAZEL
    Brand/Generic Brand
    Proprietary Name Preparation H Cooling Gel
    Proprietary Name Suffix n/a
    Non-Proprietary Name phenylephrine hcl, witch hazel
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 2.5; 500
    Active Ingredient Units mg/g; mg/g
    Substance Name PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
    Labeler Name GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part346
    Listing Certified Through 2024-12-31

    Package

    NDC 00573-2840-10 (00573284010)

    NDC Package Code 0573-2840-10
    Billing NDC 00573284010
    Package 1 TUBE in 1 CARTON (0573-2840-10) / 26 g in 1 TUBE
    Marketing Start Date 2004-01-01
    NDC Exclude Flag N
    Pricing Information N/A