Over-the-counter drug · OTC MONOGRAPH DRUG
Winco Maximum Strength Hydrocortisone (Hydrocortisone) NDC 67091-197
Hydrocortisone 10 mg/g · Cream · Topical · WINCO FOODS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67091-197-28 | 6709101972867091019728 | 1 TUBE in 1 CARTON (67091-197-28) / 28 g in 1 TUBEMarketed from Oct 12, 2020 |
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)
- Winco Maximum Strength Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- WINCO FOODS, LLCNDC labeler code 67091
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 67091-197_4253413e-385f-63ad-e063-6294a90ae488SPL ID 4253413e-385f-63ad-e063-6294a90ae488SPL set ID b1812ea3-78cc-607a-e053-2a95a90a0a10RxCUI 106258UNII WI4X0X7BPJUPC 0070552241978
- Pharmacologic class
- Corticosteroid
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
N467091019728followed by a unit qualifier and the quantityPackage 67091-0197-28. 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)
Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
Excerpt only. Read the full label for complete information.
About NDC 67091-197
- What is NDC 67091-197?
- 67091-197 is the product NDC for Winco Maximum Strength Hydrocortisone, Hydrocortisone 10 mg/g cream, listed with the FDA by WINCO FOODS, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Winco Maximum Strength Hydrocortisone (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- WINCO FOODS, LLC, NDC labeler code 67091. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Winco Maximum Strength Hydrocortisone?
- 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 016
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 |
|---|---|---|---|---|
| 2-Pack Facial Serum | Water 78.894 g/100mL + 4 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-011 |
| 2-Pack Facial Serum | 3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-012 |
| 3M Cavilon Durable Barrierdimethicone | Dimethicone 13000 mg/L | CreamTopical | Solventum US LLC | 17518-030 |
| 4% 10gTATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-031 |
| 4% TATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-030 |
| 456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis root | Salicylic acid 380 mg/50g + 3 more ingredients | CreamTopical | Guangzhou Senmai Biotechnology Co.,Ltd. | 84509-111 |
| 5% Dr.care Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-028 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-328 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-329 |
| 5% Minoxidil | Biotin .05 g/100g; Niacinamide 2.5 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-335 |
| 5% Minoxidil | Minoxidil 5 g/100g + 5 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-337 |
| 5% Minoxidil for Men and Women | Biotin .05 g/100g; Tocopherol .05 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-332 |
| 5% Minoxidil Hair Growth | Biotin .1 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-333 |
| 5% Minoxidil Hair Growth | Minoxidil 5 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-334 |
| 5% Signature Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-026 |
| 5% Signature Numb cream5% signature | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-027 |
| 5% Signature Numb cream5% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-029 |
| 70% Isopropyl Rubbing Alcoholisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | LiquidTopical | MY IMPORTS USA LLC | 51628-4501 |
| 911allantoin | Allantoin .5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-120 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
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