NDC 0573-2868
PREPARATION H Maximum Strength
Glycerin, Petrolatum, Phenylephrine Hcl, Pramoxine Hcl
PREPARATION H Maximum Strength 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 ID | 0573-2868_7f958f48-333d-4145-b3ea-745f718e8fc9 |
| NDC | 0573-2868 |
| Product Type | Human Otc Drug |
| Proprietary Name | PREPARATION H Maximum Strength |
| Generic Name | Glycerin, Petrolatum, Phenylephrine Hcl, Pramoxine Hcl |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2004-07-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Substance Name | GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE |
| Active Ingredient Strength | 144 mg/g; mg/g; mg/g; mg/g |
| Pharm Classes | 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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0573-2868-10
1 TUBE in 1 CARTON (0573-2868-10) > 26 g in 1 TUBE
| Marketing Start Date | 2004-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0573-2868-98 [00573286898]
PREPARATION H Maximum Strength CREAM
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-05-12 |
NDC 0573-2868-93 [00573286893]
PREPARATION H Maximum Strength CREAM
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-01-01 |
NDC 0573-2868-10 [00573286810]
PREPARATION H Maximum Strength CREAM
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2004-07-01 |
NDC 0573-2868-20 [00573286820]
PREPARATION H Maximum Strength CREAM
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2004-07-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GLYCERIN | 144 mg/g |
OpenFDA Data
| SPL SET ID: | 7cc03d2e-e708-589a-d9bb-58ebbda989c0 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Trademark Results [PREPARATION H]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREPARATION H 72218523 0807467 Live/Registered |
AMERICAN HOME PRODUCTS CORPORATION 1965-05-11 |
 PREPARATION H 72093736 0706552 Live/Registered |
AMERICAN HOME PRODUCTS CORPORATION 1960-03-28 |
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