Over-the-counter drug · OTC MONOGRAPH DRUG
Anti-itch Paraben Free (hydrocortisone) NDC 11383-313
Hydrocortisone 1 g/100g · Cream · Topical · Weeks & Leo Co., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11383-313-01 | 11383031301 | 1 TUBE in 1 CARTON (11383-313-01) / 28 g in 1 TUBEMarketed from Mar 3, 2023 | |
| 11383-313-02 | 11383031302 | 1 TUBE in 1 CARTON (11383-313-02) / 56 g in 1 TUBEMarketed from Mar 3, 2023 |
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)
- Anti-itch Paraben Free
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Weeks & Leo Co., Inc.
- 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 11383-313_0c5419c5-0928-7ca6-e063-6294a90ac0a7SPL ID 0c5419c5-0928-7ca6-e063-6294a90ac0a7SPL set ID 0c5419c5-0929-7ca6-e063-6294a90ac0a7RxCUI 106258UNII WI4X0X7BPJ
- 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
N411383031301followed by a unit qualifier and the quantityPackage 11383-0313-01. 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 the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, poison oak, and poison sumac cosmetics jewelry detergents soaps 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.
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 |
|---|---|---|---|---|
| Topcare Pain Relief Patchpain relief patch medicated 5% menthol | Menthol 5 g/100g | PatchTopical | 76162 | 76162-999 |
| Dit Da Shuimenthol and methyl salicylate | Menthol 100 mg/mL; Methyl salicylate 50 mg/mL | LiquidTopical | Big 5 Nutrition LLC | 82198-0006 |
| GREEN GUARD Topical Pain Relieflidocaine hci | Lidocaine hydrochloride 20 mg/mL | SprayTopical | Ultra Distributors Inc | 78495-132 |
| Medicated Body Powdermenthol | Menthol .42 g/283g | PowderTopical | Walmart Stores Inc | 79903-724 |
| lidocaine pain relief patcheslidocaine | Menthol 1.8 g/100g; Lidocaine 5 g/100g | PatchTopical | Changsha Maocheng Trading Co., Ltd | 84876-101 |
| Pain Relief Gel-Patchlidocaine 4% | Lidocaine 4 g/100g | PatchTopical | Sportpharm LLC | 85766-153 |
| Rugged Fit Pain Relief Roll Onmenthol, methyl salicylate | Menthol 2 g/100mL; Methyl salicylate 10 g/100mL | GelTopical | SYSTEM4BOOK LLC | 85826-041 |
| Rite Aid Lidocaine Patch XLargelidocaine | Lidocaine 4 g/100g | PatchTopical | Rite Aid Corporation | 11822-9992 |
| Salonpascamphor, menthol, methyl salicylate | Camphor (Synthetic) 86.24 mg/1 + 2 more ingredients | PatchPercutaneous, Topical, Transdermal | Hisamitsu Pharmaceutical Co., Inc. | 46581-210 |
| NeuroNesic Pain Relieving Creamcapsaicin | Capsaicin .1 g/100g | CreamCutaneous | Blaine Labs Inc. | 63347-999 |
| Walgreens Lidocaine Backlidocaine | Lidocaine 40 mg/g | PatchTopical | Walgreen Co. | 0363-2178 |
| Muscle Rub Creammenthol 10%, methyl salicylate 15% | Menthol 10 g/100g; Methyl salicylate 15 g/100g | CreamTopical | Trifecta Pharmaceuticals USA, LLC. | 69396-110 |
| Walgreens Cold Therapy Pain Relief Patchmenthol 5% | Menthol 5 g/100g | PatchTopical | Walgreens Company | 0363-9950 |
| Aveeno Hydrocortisone ANTI-ITCHhydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Kenvue Brands LLC | 69968-0511 |
| MyDerm Aloe and Lidocainelidocaine | Lidocaine hydrochloride .5 g/100mL | GelTopical | Inspec Solutions LLC. | 72667-283 |
| 4 Lidocaine Topical Anestheticlidocaine | Lidocaine 40 mg/g | CreamTopical | RUGBY LABORATORIES | 0536-1267 |
| Lidocaine Numbing Creamlidocaine | Lidocaine 50 mg/mL | CreamTopical | YYBA Corp | 73581-105 |
| Menthol, Camphor | Menthol 3 g/100g; Camphor (Natural) 3 g/100g | CreamTopical | EROS GLOBAL | 80465-003 |
| Menthol pain relief patchesmenthol | Capsaicin .25 g/100g; Menthol 5 g/100g | PatchTopical | Menthol pain relief patch | 84876-005 |
| Sting Relief Swabbenzocaine | Menthol, Unspecified form .006 g/.6mL; Benzocaine .12 g/.6mL | SwabTopical | 4 Visions LLC | 87251-008 |
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