Over-the-counter drug · OTC MONOGRAPH DRUG
Pramoxine Hydrochloride Anorectal (Pramoxine hydrochloride) NDC 58980-522
Pramoxine hydrochloride 1 mg/mL · Lotion · Topical · Stratus Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58980-522-40 | 5898005224058980052240 | 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLEMarketed from Nov 1, 2025 | |
| 58980-522-80 | 5898005228058980052280 | 1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLEMarketed from Nov 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Pramoxine Hydrochloride Anorectal
- Generic name (nonproprietary)
- pramoxine hydrochloride
- Active ingredients
- Pramoxine hydrochloride — 1 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Stratus PharmaceuticalsNDC labeler code 58980
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Identifiers
- Product ID 58980-522_a3ed95de-1df1-46d0-bc60-938274ffbc7dSPL ID a3ed95de-1df1-46d0-bc60-938274ffbc7dSPL set ID 39a16b66-b0e9-412f-8773-8dec0a1227e0RxCUI 1246075UNII 88AYB867L5
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
N458980052240followed by a unit qualifier and the quantityPackage 58980-0522-40. 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)
Use for the temporary relief of itching and discomfort in the perianal area.
Excerpt only. Read the full label for complete information.
About NDC 58980-522
- What is NDC 58980-522?
- 58980-522 is the product NDC for Pramoxine Hydrochloride Anorectal, Pramoxine hydrochloride 1 mg/mL lotion, listed with the FDA by Stratus Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramoxine Hydrochloride Anorectal (Pramoxine Hydrochloride).
- What is the active ingredient?
- Pramoxine hydrochloride.
- Who is the labeler?
- Stratus Pharmaceuticals, NDC labeler code 58980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pramoxine Hydrochloride Anorectal?
- 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 |
|---|---|---|---|---|
| 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 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0029 |
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