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NDC 00573-2868-98 PREPARATION H 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g Details
PREPARATION H 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g
PREPARATION H is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 00573-2868 |
|---|---|
| Product ID | 0573-2868_0a5d6aa5-e99a-e028-e063-6294a90afde6 |
| Associated GPIs | 89992004743720 |
| GCN Sequence Number | 061414 |
| GCN Sequence Number Description | phenyleph/pramoxin/glycr/w.pet CREAM (G) 0.25%-1% RECTAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 97205 |
| HICL Sequence Number | 034011 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/PRAMOXINE HCL/GLYCERIN/WHITE PETROLATUM |
| Brand/Generic | Brand |
| Proprietary Name | PREPARATION H |
| Proprietary Name Suffix | Maximum Strength |
| Non-Proprietary Name | glycerin, petrolatum, phenylephrine HCl, pramoxine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 144; 150; 2.5; 10 |
| Active Ingredient Units | mg/g; mg/g; mg/g; mg/g |
| Substance Name | GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M015 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00573-2868-98 (00573286898)
| NDC Package Code | 0573-2868-98 |
|---|---|
| Billing NDC | 00573286898 |
| Package | 1 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBE |
| Marketing Start Date | 2020-05-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |