Over-the-counter drug · OTC MONOGRAPH DRUG
HemorrhoidalOintment NDC 68016-528
mineral oil, petrolatum, phenylephrine hci · Mineral oil 14 g/100g + 2 more ingredients · Ointment · Topical · Pharmacy Value Alliance, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-528-00 | 6801605280068016052800 | 1 TUBE in 1 BOX (68016-528-00) / 57 g in 1 TUBEMarketed from Jul 19, 2016 |
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)
- HemorrhoidalOintment
- Generic name (nonproprietary)
- mineral oil, petrolatum, phenylephrine hci
- Active ingredients
- Mineral oil — 14 g/100gPetrolatum — 74.9 g/100gPhenylephrine hydrochloride — .25 g/100g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Pharmacy Value Alliance, LLCNDC labeler code 68016
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 68016-528_29b76842-546d-6826-e063-6294a90a20a5SPL ID 29b76842-546d-6826-e063-6294a90a20a5SPL set ID 3803a61b-308a-14a9-e054-00144ff88e88RxCUI 1372298UNII T5L8T28FGP, 4T6H12BN9U, 04JA59TNSJUPC 0840986014109
- Pharmacologic class
- 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
N468016052800followed by a unit qualifier and the quantityPackage 68016-0528-00. 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 Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning 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 68016-528
- What is NDC 68016-528?
- 68016-528 is the product NDC for HemorrhoidalOintment, Mineral oil 14 g/100g + 2 more ingredients ointment, listed with the FDA by Pharmacy Value Alliance, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- HemorrhoidalOintment (Mineral Oil, Petrolatum, Phenylephrine HCI).
- What is the active ingredient?
- Mineral oil, Petrolatum, Phenylephrine hydrochloride.
- Who is the labeler?
- Pharmacy Value Alliance, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for HemorrhoidalOintment?
- 4 other product NDCs are listed under this name. See all HemorrhoidalOintment NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other HemorrhoidalOintment products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-133 | 69396-0133-20 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Petrolatum 74.9 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-083 | 69396-0083-01 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-082 | 69396-0082-02 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-020 | 69396-0020-0169396-0020-0269396-0020-33+1 more |
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 |
|---|---|---|---|---|
| Dr. Numblidocaine | Lidocaine 5 g/100mL | CreamTopical | Shinpharma Inc | 69903-006 |
| Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Bryant Ranch Prepack | 72162-2282 |
| Numbskin Maximum Strength Pain Relieverlidocaine | Lidocaine 5 g/100mL | CreamTopical | Shinpharma Inc | 69903-008 |
| equate hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Wal-Mart Stores Inc | 49035-944 |
| Medpride Relieflidocaine 5% | Lidocaine 50 mg/g | CreamTopical | Shield Line LLC | 52410-1090 |
| RectaEase Hemorrhoid Relief Creamlidocaine | Lidocaine 50 mg/g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-070 |
| Drmitsui Medical Haemorrhoidphenylephrine hci witch hazel | Witch hazel 50 g/100g; Phenylephrine hydrochloride .25 g/100g | GelTopical | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 87267-011 |
| ProCure Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Petrolatum 74.9 g/100g + 2 more ingredients | OintmentRectal, Topical | Twin Med LLC | 55681-021 |
| Lidocaine Numbing Creamlidocaine | Lidocaine .05 g/g | CreamTopical | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 83602-311 |
| Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Shield Line LLC | 52410-1820 |
| Rectal Care Cream | Lidocaine 5 g/100g | CreamRectal, Topical | Allegiant Health | 69168-484 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-082 |
| HemorrhoidalOintmentmineral oil, petrolatum, phenylephrine hci | Petrolatum 74.9 g/100g + 2 more ingredients | OintmentTopical | Trifecta Pharmaceuticals USA LLC | 69396-083 |
| Signature Care Hemorrhoidal Cream (with applicator)phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum | Phenylephrine hydrochloride 2.5 mg/g + 3 more ingredients | CreamTopical | BETTER LIVING BRANDS, LLC | 21130-981 |
| CAREALL Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 140 mg/g + 2 more ingredients | OintmentTopical | New World Imports, Inc | 51824-079 |
| Preparation H For Womenwitch hazel | Witch hazel 2 g/1 | ClothTopical | Haleon US Holdings LLC | 0573-0559 |
| Equaline Hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | United Natural Foods, Inc. dba UNFI | 41163-944 |
| TheraCare Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentRectal | Veridian Healthcare | 71101-935 |
| Bunnies Bum Soothing Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hcl | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | FloCal Distributors LLC | 84308-161 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
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