Over-the-counter drug · OTC MONOGRAPH DRUG
Banophen NDC 0904-5354
diphenhydramine hydrochloride, zinc acetate · Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g · Cream · Topical · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5354-31 | 0090453543100904535431 | 1 TUBE in 1 CARTON (0904-5354-31) / 28 g in 1 TUBEMarketed from Jun 19, 2009 |
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)
- Banophen
- Generic name (nonproprietary)
- diphenhydramine hydrochloride, zinc acetate
- Active ingredients
- Diphenhydramine hydrochloride — 2 g/100gZinc acetate — .1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-5354_9d9d4074-238a-49d0-a5ef-39414da07434SPL ID 9d9d4074-238a-49d0-a5ef-39414da07434SPL set ID 9758d886-bd58-4eb2-a827-fa8e7fee2b7cRxCUI 1087026, 1092428UNII TC2D6JAD40, FM5526K07A
- Pharmacologic class
- Copper Absorption Inhibitor; Histamine-1 Receptor Antagonist
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
N400904535431followed by a unit qualifier and the quantityPackage 00904-5354-31. 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 • temporarily relieves pain and itching associated with: • insect bites • minor burns • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison ivy, poison oak and poison sumac • dries the oozing and weeping of poison ivy, poison oak and poison sumac
Excerpt only. Read the full label for complete information.
About NDC 0904-5354
- What is NDC 0904-5354?
- 0904-5354 is the product NDC for Banophen, Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g cream, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Banophen (Diphenhydramine Hydrochloride, Zinc Acetate).
- What is the active ingredient?
- Diphenhydramine hydrochloride, Zinc acetate.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Banophen?
- 8 other product NDCs are listed under this name. See all Banophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Banophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Health Department, Oklahoma State | 83112-555 | 83112-0555-59 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7830 | 68788-7830-0168788-7830-03 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-5307 | 00904-5307-6000904-5307-80 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9451 | 63629-9451-0163629-9451-02 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0081 | 71335-0081-0071335-0081-0171335-0081-02+7 more |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-5551 | 00904-5551-2400904-5551-59 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5546 | 50090-5546-00 |
| Banophendiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-611 | 71205-0611-2071205-0611-3071205-0611-60+1 more |
Other NDCs under M 017
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 |
|---|---|---|---|---|
| Stopain Extra Strength Continuousmenthol | Menthol 80 mg/mL | SprayTopical | Troy Manufacturing, Inc. | 63936-4850 |
| Fast Freeze Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 33 mg/mL | GelTopical | NATURAL ESSENTIALS, INC. | 66902-116 |
| Walgreens Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | Walgreens Company | 0363-5061 |
| Blt 2lidocaine hcl | Lidocaine hydrochloride 4 g/100g | OintmentTopical | CENTURA PHARMACEUTICALS INC | 70372-728 |
| Lidocaine 4% Patchlidocaine 4% | Lidocaine 40 mg/g | PatchTopical | V2 Pharma, LLC | 72835-400 |
| Just Cbd Roll-On Coolingmenthol | Menthol 4 g/100mL | GelTopical | Just Brands LLC | 73647-400 |
| Magsoothium Body Cooling Formulamenthol | Menthol 5 g/100mL | CreamTopical | Ubu/Elements, Inc. | 83262-002 |
| Rapid Reliefpain relief patch camphor 110mg menthol 33mg capsicum extract 22mg | Levomenthol .3 g/100g + 2 more ingredients | PatchTopical | RAPID AID VIET NAM COMPANY LIMITED | 83569-015 |
| Terramed Just Think Comfort Hydrocortisone 1% Creamhydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Rida LLC | 83004-051 |
| Tktalker Numbingnumbing | Lidocaine 4 g/100g | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-113 |
| Herb Street Backache and Sore Muscle Reliefmenthol | Menthol .1 g/g | StickTopical | Balassa Laboratories Inc. | 10107-432 |
| CBD Pain Relief Creamtrolamine salicylate | Trolamine salicylate 100 mg/g | CreamTopical | Allure Labs | 62742-4198 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Hush Anestheticlidocaine | Lidocaine 40 mg/g | GelTopical | HUSH Anesthetic | 49947-002 |
| Jointivatrolamine salicylate 10% | Trolamine salicylate 10 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-355 |
| Stopain Clinicalmenthol, unspecified form | Menthol, Unspecified form 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-0975 |
| Coralite Lidocaine 4% Flexible Pain Relief Patch 1ctlidocaine pain patch | Lidocaine 40 mg/g | PatchTopical | United Exchange Corp | 65923-579 |
| Desert Harvest RELEVEUMlidocaine | Lidocaine 40 mg/mL | CreamTopical | Desert Harvest Inc. | 69145-201 |
| A Health Itch Relief Gelitch relief gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Bionpharma, Inc. | 69452-496 |
| Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylatetrolamine salicylate | Trolamine salicylate 10 g/100g | CreamTopical | TELEBRANDS CORP | 73287-032 |
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