Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine Phenolated Topical Suspension (Calamine and zinc oxide and phenol) NDC 0395-0407
Zinc oxide 160 mg/mL; Phenol 10 mg/mL · Lotion · Topical · Humco Holding Group, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0395-0407-96 | 0039504079600395040796 | 177 mL in 1 BOTTLE, PLASTIC (0395-0407-96)Marketed from Nov 13, 2017 |
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)
- Calamine Phenolated Topical Suspension
- Generic name (nonproprietary)
- calamine and zinc oxide and phenol
- Active ingredients
- Zinc oxide — 160 mg/mLPhenol — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Humco Holding Group, IncNDC labeler code 0395
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 0395-0407_0c92d58b-b1c7-dc2c-e063-6394a90a4d7aSPL ID 0c92d58b-b1c7-dc2c-e063-6394a90a4d7aSPL set ID a3816729-be2b-4b4f-a609-953576cd2e3bRxCUI 991369UNII SOI2LOH54Z, 339NCG44TVUPC 0303950407968
- Pharmacologic class
- Copper Absorption Inhibitor
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
N400395040796followed by a unit qualifier and the quantityPackage 00395-0407-96. 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 Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations
Excerpt only. Read the full label for complete information.
About NDC 0395-0407
- What is NDC 0395-0407?
- 0395-0407 is the product NDC for Calamine Phenolated Topical Suspension, Zinc oxide 160 mg/mL; Phenol 10 mg/mL lotion, listed with the FDA by Humco Holding Group, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calamine Phenolated Topical Suspension (Calamine and Zinc Oxide and Phenol).
- What is the active ingredient?
- Zinc oxide, Phenol.
- Who is the labeler?
- Humco Holding Group, Inc, NDC labeler code 0395. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calamine Phenolated Topical Suspension?
- 1 other product NDC are listed under this name. See all Calamine Phenolated Topical Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calamine Phenolated Topical Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calamine Phenolated Topical Suspensioncalamine and zinc oxide and phenol | Zinc oxide 160 mg/mL; Phenol 10 mg/mL | LotionTopical | Pharma Nobis, LLC | 82645-921 | 82645-0921-96 |
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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