Over-the-counter drug · OTC MONOGRAPH DRUG
Thera plus Anti-itch with aloe Hydrocortisone (Hydrocortisone) NDC 80684-038
Hydrocortisone 10 mg/g · Cream · Topical · Fourstar Group USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80684-038-01 | 8068400380180684003801 | 1 TUBE in 1 BOX (80684-038-01) / 28 g in 1 TUBEMarketed from Jan 30, 2022 |
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)
- Thera plus Anti-itch with aloe Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Fourstar Group USA, Inc.NDC labeler code 80684
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80684-038_08a0f5fb-bc99-45d2-e063-6294a90a623cSPL ID 08a0f5fb-bc99-45d2-e063-6294a90a623cSPL set ID c69d0670-a65b-1680-e053-2995a90a2ee5RxCUI 106258UNII WI4X0X7BPJUPC 0049696865906
- 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
N480684003801followed by a unit qualifier and the quantityPackage 80684-0038-01. 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 itching associated with minor skin irritations, inflammation and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should be under advice and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 80684-038
- What is NDC 80684-038?
- 80684-038 is the product NDC for Thera plus Anti-itch with aloe Hydrocortisone, Hydrocortisone 10 mg/g cream, listed with the FDA by Fourstar Group USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Thera plus Anti-itch with aloe Hydrocortisone (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Fourstar Group USA, Inc., NDC labeler code 80684. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Thera plus Anti-itch with aloe 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 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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|---|---|---|---|---|
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| 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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