Over-the-counter drug · OTC MONOGRAPH DRUG
Family Wellness NDC 69571-004
glycerin, phenylephrine hcl, pramoxine hcl, petrolatum · Glycerin 14.4 g/100g + 3 more ingredients · Cream · Topical · FRONT PHARMACEUTICAL PLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69571-004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69571-0004Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69571-004-02 | 6957100040269571000402 | 1 TUBE in 1 BOX (69571-004-02) / 26 g in 1 TUBE (69571-004-01)Marketed from Mar 14, 2017 |
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)
- Family Wellness
- Generic name (nonproprietary)
- glycerin, phenylephrine hcl, pramoxine hcl, petrolatum
- Active ingredients
- Glycerin — 14.4 g/100gPhenylephrine hydrochloride — .25 g/100gPramoxine hydrochloride — 1 g/100gPetrolatum — 15 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- FRONT PHARMACEUTICAL PLCNDC labeler code 69571
- 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 69571-004_08a17869-d45f-18ce-e063-6394a90adbbbSPL ID 08a17869-d45f-18ce-e063-6394a90adbbbSPL set ID eb1785f4-5876-443b-b175-9b59d65d1a48RxCUI 1293649UNII PDC6A3C0OX, 04JA59TNSJ, 88AYB867L5, 4T6H12BN9UUPC 0032251238215
- 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
N469571000402followed by a unit qualifier and the quantityPackage 69571-0004-02. 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 69571-004
- What is NDC 69571-004?
- 69571-004 is the product NDC for Family Wellness, Glycerin 14.4 g/100g + 3 more ingredients cream, listed with the FDA by FRONT PHARMACEUTICAL PLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Family Wellness (Glycerin, Phenylephrine HCl, Pramoxine HCl, Petrolatum).
- What is the active ingredient?
- Glycerin, Phenylephrine hydrochloride, Pramoxine hydrochloride, Petrolatum.
- Who is the labeler?
- FRONT PHARMACEUTICAL PLC, NDC labeler code 69571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Family Wellness?
- 10 other product NDCs are listed under this name. See all Family Wellness NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Family Wellness products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Family Wellnessbenzocaine, resorcinol | Benzocaine 20 g/100g; Resorcinol 3 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | 55621-016 | 55621-0016-01 |
| Family Wellnesshydrocortisone 1% | Hydrocortisone 1 g/100g | CreamTopical | FRONT PHARMACEUTICAL PLC | 69571-009 | 69571-0009-01 |
| Family Wellnessbacitracin zinc | Bacitracin zinc .51 g/100g | OintmentTopical | FRONT PHARMACEUTICAL PLC | 69571-008 | 69571-0008-01 |
| Family wellnessmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | FRONT PHARMACEUTICAL PLC | 69571-006 | 69571-0006-02 |
| Family Wellnessdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g | CreamTopical | FRONT PHARMACEUTICAL PLC | 69571-005 | 69571-0005-02 |
| Family wellnessbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc .41 g/100g + 2 more ingredients | OintmentTopical | FRONT PHARMACEUTICAL PLC | 69571-003 | 69571-0003-02 |
| Family Wellnessglycerin, phenylephrine hydrochloride, pramoxine hydrochloride, petrolatum | Glycerin 14.4 g/100g + 3 more ingredients | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-012 | 55621-0012-01 |
| Family Wellnessphenylephrine hcl, petrolatum, mineral | Phenylephrine hydrochloride .25 g/100g + 2 more ingredients | OintmentRectal, Topical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-006 | 55621-0006-01 |
| Family Wellnessdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-007 | 55621-0007-01 |
| Family Wellnesshydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-008 | 55621-0008-01 |
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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