Over-the-counter drug · OTC MONOGRAPH DRUG
FixMySkin Healing Balm Fragrance-Free (Hydrocortisone) NDC 76314-002
Hydrocortisone 10 mg/mL · Ointment · Topical · Lovely Skin, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76314-002-03 | 7631400020376314000203 | 14.78 mL in 1 PACKAGE (76314-002-03)Marketed from Nov 17, 2011 |
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)
- FixMySkin Healing Balm Fragrance-Free
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/mL
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Lovely Skin, Inc.NDC labeler code 76314
- 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 76314-002_2a934860-029e-a463-e063-6294a90aa446SPL ID 2a934860-029e-a463-e063-6294a90aa446SPL set ID c12af4c6-2f05-46ec-b901-1a4fcd750180RxCUI 203105UNII WI4X0X7BPJUPC 0376314000099
- 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
N476314000203followed by a unit qualifier and the quantityPackage 76314-0002-03. 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)
Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.
Excerpt only. Read the full label for complete information.
About NDC 76314-002
- What is NDC 76314-002?
- 76314-002 is the product NDC for FixMySkin Healing Balm Fragrance-Free, Hydrocortisone 10 mg/mL ointment, listed with the FDA by Lovely Skin, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- FixMySkin Healing Balm Fragrance-Free (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Lovely Skin, Inc., NDC labeler code 76314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for FixMySkin Healing Balm Fragrance-Free?
- 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 |
|---|---|---|---|---|
| Aosi Healthcare Burnlidocaine hydrochloride, benzalkonium chloride | Lidocaine hydrochloride .5 g/100g; Benzalkonium chloride .13 g/100g | CreamTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-055 |
| Satohap Cool Typecamphor, menthol, methyl salicylate | Camphor (Synthetic) 5 g/100mL + 2 more ingredients | LotionTopical | Sato Pharmaceutical Co., Ltd. | 49873-620 |
| Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesiclidocaine hydrochloride | Lidocaine hydrochloride 8 mg/g | GelTopical | WEGMANS FOOD MARKETS INC | 47124-129 |
| Walgreens Burn Padburn pad | Lidocaine 4.1 g/100g | PatchTopical | Walgreens | 0363-2789 |
| Extra Large Cool and Heat Patchmenthol | Menthol 5 g/100g | PatchTopical | Walgreen Company | 0363-9905 |
| Maximum Strength Cortisone Cream with Aloehydrocortisone cream | Hydrocortisone 1 g/100g | CreamTopical | CVS Pharmacy | 69842-630 |
| hydrocortisone | Hydrocortisone 1 g/100g | OintmentTopical | Bryant Ranch Prepack | 72162-2284 |
| Menthol, Camphor | Menthol 10 g/100g; Camphor (Natural) 3 g/100g | CreamTopical | SUNSET NOVELTIES, INC | 72937-103 |
| Mineral Ice Methol Pain Reliefmenthol 10.5 % | Menthol 10.5 g/100g | SprayTopical | Sunflora Inc | 73240-905 |
| Equate Hydrocortisone Topicalhydrocortisone | Hydrocortisone .01 g/g | CreamTopical | WalMart | 79903-091 |
| Morovanlidocaine | Lidocaine 4 g/100g | CreamTopical | HONG KONG UNORDERED TRADING CO., LIMITED | 87800-2624 |
| Eucerin Skin Calming Itch Relief Treatmentmenthol | Menthol .1 g/100mL | LotionTopical | Beiersdorf Inc | 10356-357 |
| Cortizone 10 Intensive Healinghydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Chattem, Inc. | 41167-0035 |
| Satogesic Hotcapsaicin | Capsaicin .25 mg/1 | PatchTopical | Sato Pharmaceutical Co., Ltd. | 49873-608 |
| CAREALL Hydrocortisone Maximum Strengthhydrocortisone | Hydrocortisone .01 g/g | CreamTopical | New World Imports, Inc. | 51824-197 |
| CVS Cold and Hot Pain Relief Drylidocaine, menthol | Menthol, Unspecified form 10 mg/g; Lidocaine 40 mg/g | SprayTopical | CVS Pharmacy | 51316-483 |
| Pain Relieving Cream Lidocainebenzyl alcohol, lidocaine hci | Lidocaine hydrochloride 4 g/100g; Benzyl alcohol 10 g/100g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-139 |
| CVS Anti-Itchcamphor, menthol | Camphor (Synthetic) .5 g/100g; Menthol .5 g/100g | LotionTopical | CVS | 69842-626 |
| External Analgesiccamphor, capsicum, menthol | Camphor (Synthetic) 96 mg/g + 2 more ingredients | PatchTopical | Hmong 21 | 70927-001 |
| Doctor Hoys Pain Relief Gelmenthol, camphor (synthetic) | Menthol 50 mg/mL; Camphor (Synthetic) 50 mg/mL | GelTopical | Dynamic Blending Specialists, Inc. | 75638-010 |
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