Over-the-counter drug · OTC MONOGRAPH DRUG
Dermachange Aid Anti-Itch (Diphenhydramine hcl) NDC 83520-107
Diphenhydramine hydrochloride 2 g/100mL · Gel · Topical · Private Label Beauty and Wellness
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83520-107-03 | 8352001070383520010703 | 104 mL in 1 TUBE (83520-107-03)Marketed from Jan 31, 2024 |
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)
- Dermachange Aid Anti-Itch
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 2 g/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Private Label Beauty and WellnessNDC labeler code 83520
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83520-107_12ed906c-d027-0ff7-e063-6394a90aaa52SPL ID 12ed906c-d027-0ff7-e063-6394a90aaa52SPL set ID 12ed906c-d028-0ff7-e063-6394a90aaa52RxCUI 1049880UNII TC2D6JAD40UPC 0850040138443
- Pharmacologic class
- 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
N483520010703followed by a unit qualifier and the quantityPackage 83520-0107-03. 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)
For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.
Excerpt only. Read the full label for complete information.
About NDC 83520-107
- What is NDC 83520-107?
- 83520-107 is the product NDC for Dermachange Aid Anti-Itch (diphenhydramine hcl), Diphenhydramine hydrochloride 2 g/100mL gel, listed with the FDA by Private Label Beauty and Wellness. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dermachange Aid Anti-Itch (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Private Label Beauty and Wellness, NDC labeler code 83520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dermachange Aid Anti-Itch?
- 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 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 |
Showing 20 of 40.