Over-the-counter drug · OTC MONOGRAPH DRUG
PREPARATION H Maximum Strength NDC 0573-2868
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl · Glycerin 144 mg/g + 3 more ingredients · Cream · Topical · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-2868-10 | 0057328681000573286810 | 1 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBEMarketed from Jul 1, 2004 | |
| 0573-2868-20 | 0057328682000573286820 | 1 TUBE in 1 CARTON (0573-2868-20) / 51 g in 1 TUBEMarketed from Jul 1, 2004 | |
| 0573-2868-93 | 0057328689300573286893 | 1 TUBE in 1 CARTON (0573-2868-93) / 26 g in 1 TUBEMarketed from Jan 1, 2019 | |
| 0573-2868-98 | 0057328689800573286898 | 1 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBEMarketed from May 12, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- PREPARATION H Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl
- Active ingredients
- Glycerin — 144 mg/gPhenylephrine hydrochloride — 2.5 mg/gPramoxine hydrochloride — 10 mg/gPetrolatum — 150 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Glycerol (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
- Identifiers
- Product ID 0573-2868_15581b30-e814-550a-e063-6394a90a3aaeSPL ID 15581b30-e814-550a-e063-6394a90a3aaeSPL set ID 7cc03d2e-e708-589a-d9bb-58ebbda989c0RxCUI 1293649UNII PDC6A3C0OX, 04JA59TNSJ, 88AYB867L5, 4T6H12BN9U
- Pharmacologic class
- Non-Standardized Chemical Allergen; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400573286810followed by a unit qualifier and the quantityPackage 00573-2868-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses for temporary relief of pain, soreness and burning helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Excerpt only. Read the full label for complete information.
About NDC 0573-2868
- What is NDC 0573-2868?
- 0573-2868 is the product NDC for PREPARATION H Maximum Strength, Glycerin 144 mg/g + 3 more ingredients cream, listed with the FDA by Haleon US Holdings LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PREPARATION H Maximum Strength (Glycerin, petrolatum, phenylephrine HCl, pramoxine HCl).
- What is the active ingredient?
- Glycerin, Phenylephrine hydrochloride, Pramoxine hydrochloride, Petrolatum.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PREPARATION H Maximum Strength?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 015
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pramoxine Hydrochloride Anorectalpramoxine hydrochloride | Pramoxine hydrochloride 1 mg/mL | LotionTopical | Stratus Pharmaceuticals | 58980-522 |
| Ma Ying Long Musk Hemorrhoidspetrolatum, zinc oxide | Petrolatum 779.9 mg/g; Zinc oxide 76 mg/g | OintmentTopical | Mayinglong Pharmaceutical Group Co., Ltd. | 68511-997 |
| Mayinglong Hemorrhoidalpetrolatum, zinc oxide | Petrolatum 779.9 mg/g; Zinc oxide 76 mg/g | OintmentTopical | Mayinglong Pharmaceutical Group Co., Ltd. | 68511-998 |
| hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Kroger Company | 30142-944 |
| Preparation Hcocoa butter, phenylephrine hydrochloride, and witch hazel | — | Kit | Haleon US Holdings LLC | 0573-2884 |
| Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Kroger Company | 30142-188 |
| rexall hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | Dolgencorp Inc | 55910-279 |
| Witch Hazel | Witch hazel 860 mg/mL | LiquidTopical | CVS Pharmacy, Inc. | 59779-045 |
| Dermatool Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hcl | Lidocaine 5 g/100g + 3 more ingredients | CreamTopical | Papalo Group LLC | 84728-413 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0028 |
| Hemorrhoid Anestheticmineral oil, petrolatum, phenylephrine hcl | Petrolatum .749 g/g + 2 more ingredients | OintmentTopical | Savvy Care and Cosmetics | 83650-110 |
| hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | Meijer Distribution Inc | 41250-279 |
| Lidocaine Numbing Creamlidocaine | Lidocaine .05 g/g | CreamTopical | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 73557-311 |
| RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)lidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0027 |
| Barrier Protectant Creambarrier cream | Menthol 1 mg/g; Zinc oxide 200 mg/g | OintmentTopical | Cardinal Health | 63517-003 |
| ER Hemorrhoidphenylephrine hcl | Mineral oil .14 g/g + 2 more ingredients | CreamRectal | EVER READY FIRST AID | 72976-018 |
| ANIXIKE Numbinglidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-166 |
| Meijer Maximum strength pain relieving cleansingbenzalkonium chloride and lidocaine hydrochloride | Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL | LiquidTopical | MEIJER DISTRIBUTION, INC. | 41250-287 |
| hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Meijer Distribution Inc | 41250-944 |
| Equaline Hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | United Natural Foods, Inc. dba UNFI | 41163-279 |
Showing 20 of 40.