Over-the-counter drug · OTC MONOGRAPH DRUG
Itch Relief (Hydrocortisone 1%) NDC 69396-057
Hydrocortisone 1 g/100g · Cream · Topical · Trifecta Pharmaceuticals USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69396-057-01 | 6939600570169396005701 | 1 TUBE in 1 BOX (69396-057-01) / 28 g in 1 TUBEMarketed from Sep 17, 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)
- Itch Relief
- Generic name (nonproprietary)
- hydrocortisone 1%
- Active ingredients
- Hydrocortisone — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Trifecta Pharmaceuticals USA LLCNDC labeler code 69396
- 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 69396-057_29b36988-b625-40f2-e063-6294a90a39b8SPL ID 29b36988-b625-40f2-e063-6294a90a39b8SPL set ID af5daf6c-bcad-8ebf-e053-2a95a90af1b0RxCUI 106258UNII WI4X0X7BPJUPC 0050428265338
- 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
N469396005701followed by a unit qualifier and the quantityPackage 69396-0057-01. 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 For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to Eczema Insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis sunburn temporarily relieves external anal and genital itching. Other uses of this product should be only under the advice and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 69396-057
- What is NDC 69396-057?
- 69396-057 is the product NDC for Itch Relief (hydrocortisone 1%), Hydrocortisone 1 g/100g cream, listed with the FDA by Trifecta Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Itch Relief (Hydrocortisone 1%).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Trifecta Pharmaceuticals USA LLC, NDC labeler code 69396. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Itch Relief?
- 14 other product NDCs are listed under this name. See all Itch Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Itch Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Itch Reliefitch relief gel | Diphenhydramine hydrochloride 20 mg/mL | GelTopical | Neilmed Pharmaceuticals Inc. | 13709-351 | 13709-0351-01 |
| Itch Reliefdiphenhydramine hcl, zinc acetate | Zinc acetate 1 mg/g; Diphenhydramine hydrochloride 20 mg/g | Aerosol, SprayTopical | HY-VEE, INC | 42507-986 | 42507-0986-76 |
| Itch Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 20 mg/mL | SprayTopical | FSA Store Inc. | 81522-751 | 81522-0751-25 |
| itch reliefdiphenhydramine hydrochloride and zinc acetate | Zinc acetate 1 mg/g; Diphenhydramine hydrochloride 20 mg/g | CreamTopical | Bionpharma Inc. | 69452-449 | 69452-0449-37 |
| Itch Reliefdiphenhydramine hcl, zinc acetate | Zinc acetate 1 mg/mL; Diphenhydramine hydrochloride 20 mg/mL | SprayTopical | The Kroger Co. | 59450-295 | 59450-0295-20 |
| Itch Reliefhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1215 | 70677-1215-01 |
| Itch Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 20 mg/mL | SprayTopical | Wal-Mart Stores, Inc. | 79903-217 | 79903-0217-25 |
| Itch Reliefdiphenhydramine hcl and zinc acetate | Diphenhydramine hydrochloride 1.5 g/76g; Zinc acetate .076 g/76g | Aerosol, SprayTopical | CVS Pharmacy | 69842-235 | 69842-0235-27 |
| Itch Reliefdiphenhydramine hcl, zinc acetate | Diphenhydramine hydrochloride 20 mg/mL; Zinc acetate 1 mg/mL | SprayTopical | Meijer, Inc. | 41250-295 | 41250-0295-20 |
| Itch Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 20.3 g/L | LiquidTopical | Safetec of America, Inc. | 61010-8300 | 61010-8300-01 |
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 |
|---|---|---|---|---|
| Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate | Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g | SprayTopical | Meijer Distribution Inc | 79481-0598 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Meijer Pain Relieving Balm Analgesictrolamine salicylate | Trolamine salicylate 10 mg/g | CreamTopical | Meijer Distribution, Inc | 41250-356 |
| Ralli Rapid Pain Relief Roll onmenthol | Menthol 100 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9527 |
| CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate | Camphor (Synthetic) 28 mg/1 + 2 more ingredients | PatchTransdermal | Natural Essentials, Inc. | 66902-280 |
| Pbz Otctripelennamine hcl 1% | Tripelennamine 1 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-151 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Henry Schein | 0404-0166 |
| American Safety and First Aidhydrocortisone acetate | Hydrocortisone acetate 10 mg/g | CreamTopical | Orazen Inc | 71927-015 |
| MyDerm Bite Reliefbenzocaine | Benzocaine 5 g/100g | OintmentTopical | Inspec Solutions LLC. | 72667-019 |
| Thera Plus Maximum Strength Hydrocortisonehydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Fourstar Group USA, Inc | 80684-197 |
| Lidocaine 4% | Lidocaine 400 mg/10g | PatchTransdermal | Marcella Health | 85096-201 |
| Tough Love Pain Relievinglidocaine hcl | Lidocaine 4 g/100g | CreamTopical | Allure Labs | 62742-4222 |
| Stopain Extra Strength Gelmenthol | Menthol 80 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9506 |
| Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol | Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL | LiquidTopical | Natural Essentials, Inc. | 66902-235 |
| Walgreens pain relievinglidocaine 4% | Lidocaine 4 g/100g | Aerosol, SprayTopical | Walgreens | 0363-3038 |
| Bikini Zone Medicated Cremelidocaine | Lidocaine 2 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-043 |
| American Safety First Aidlidocaine hcl | Lidocaine hydrochloride 20 mg/mL | SprayTopical | Orazen Inc | 71927-012 |
| ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-617 |
| Healmusz Eczemahydrocortisone 1% eczema | Hydrocortisone 1 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-203 |
| ELAIMEI Numbing Creamlidocaine 4% | Lidocaine 4 g/100mL | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-005 |
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