Over-the-counter drug · OTC MONOGRAPH DRUG
Lidocaine NDC 58980-824
Lidocaine 40 mg/g · Cream · Topical · Stratus Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58980-824-05 | 58980082405 | 1 TUBE in 1 BOX (58980-824-05) / 14.17 g in 1 TUBEMarketed from Sep 20, 2024 | |
| 58980-824-15 | 58980082415 | 5 TUBE in 1 BOX, UNIT-DOSE (58980-824-15) / 5 g in 1 TUBEMarketed from Sep 20, 2024 | |
| 58980-824-30 | 58980082430 | 1 TUBE in 1 BOX (58980-824-30) / 28.35 g in 1 TUBEMarketed from Feb 15, 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)
- Lidocaine
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 40 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Stratus Pharmaceuticals IncNDC labeler code 58980
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 58980-824_6d26e7b3-bcd8-46de-9ae1-6010b4014fc1SPL ID 6d26e7b3-bcd8-46de-9ae1-6010b4014fc1SPL set ID e1a8d4a7-01f7-4bab-8d09-875c461b3b61RxCUI 1421893UNII 98PI200987
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic
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
N458980082405followed by a unit qualifier and the quantityPackage 58980-0824-05. 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 pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations
Excerpt only. Read the full label for complete information.
About NDC 58980-824
- What is NDC 58980-824?
- 58980-824 is the product NDC for Lidocaine, Lidocaine 40 mg/g cream, listed with the FDA by Stratus Pharmaceuticals Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine.
- What is the active ingredient?
- Lidocaine.
- Who is the labeler?
- Stratus Pharmaceuticals Inc, NDC labeler code 58980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lidocaine?
- 158 other product NDCs are listed under this name. See all Lidocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Direct_Rx | 72189-692 | 72189-0692-50 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4195 | 68788-4195-05 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Ascend Laboratories, LLC | 67877-767 | 67877-0767-30 |
| Lidocaine | Lidocaine 80 mg/mL | SprayTopical | YYBA CORP | 73581-900 | 73581-0900-01 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 | 80425-0594-01 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Sentiss Pharmaceuticals LLC | 70244-039 | 70244-0039-0170244-0039-02 |
| Lidocaine | Lidocaine 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-002 | 87879-0002-02 |
| Lidocainelidicaine | Lidocaine 50 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-107 | 21922-0107-1321922-0107-61 |
| Lidocaine | Lidocaine hydrochloride 50 mg/mL | GelTopical | YYBA Corp | 73581-115 | 73581-0115-03 |
| Lidocaine | Lidocaine 5 g/100mL | CreamTopical | YYBA Corp | 73581-022 | 73581-0022-06 |
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 |
|---|---|---|---|---|
| anti itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Meijer, Inc. | 79481-0973 |
| Bliss Republiclidocaine numbing extra strength cream | Lidocaine hydrochloride 4 mg/100mL | CreamTopical | Sargass Group Limited Liability Company | 84028-124 |
| Cheong Kun Pain Relievingcamphor | Camphor (Synthetic) .2 g/100mL | OilTopical | CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED | 87731-001 |
| Signature Care Cold and Hot Medicatedmenthol | Menthol, Unspecified form 50 mg/1 | PatchTopical | Safeway | 21130-980 |
| Medistik Icementhol, camphor | Menthol 10 g/100mL; Camphor oil 4 g/100mL | SolutionTopical | Natureteq Inc. | 50231-411 |
| Katinko External Analgesic Oilcamphor (synthetic), menthol, methyl salicylate | Camphor (Synthetic) 50 mg/mL + 2 more ingredients | OilTopical | Greenstone Pharmaceutical Inc. | 52241-301 |
| Lidoease 2%lidocaine hcl 2% | Lidocaine hydrochloride 20 mg/g | GelTopical | PureTek Corporation | 59088-221 |
| Biofreeze Professional Roll-Onmenthol, unspecified form | Menthol, Unspecified form 50 mg/mL | GelTopical | Reckitt Benckiser LLC | 59316-117 |
| Good Neighbor Pharmacy Hydrocortisonehydrocortisone | Hydrocortisone 1 g/100g | OintmentTopical | AmerisourceBergen | 24385-276 |
| DIRT Pain Relieving Gelmenthol | Menthol 40 mg/mL | GelTopical | PURIVITAE, LLC | 83067-363 |
| CVS Pain Relief Lavender Scentmenthol 4% | Menthol, (+)- 4 g/100mL | GelTopical | CVS | 51316-118 |
| DG Health Cold n Hot Pain Relieving Topical Analgesicmenthol, unspecified form | Menthol, Unspecified form 160 mg/mL | LiquidTopical | Dolgencorp Inc | 55910-883 |
| Biofreezementhol | Menthol, Unspecified form 105 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-114 |
| Flanax Back Pain Relieflidocaine | Lidocaine 4 g/1 | PatchTopical | Belmora LLC | 27854-333 |
| Anti Itchdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g | CreamTopical | Meijer Distribution Inc | 41250-622 |
| Pain Relieving Patchescamphor menthol methyl salicytate | Camphor (Synthetic) 1.2 g/100g + 2 more ingredients | PatchTopical | Walgreen Company | 0363-9903 |
| Teeter reNEW MUSCLES Pain Relievingmethyl salicylate, menthol | Methyl salicylate 10 mg/g; Menthol 7 mg/g | CreamTopical | STL International INC | 70329-717 |
| HealthWise Roll-On Lidocaine Pain Relief Liquidlidocaine hci | Lidocaine 4 g/mL | LiquidTopical | Veridian Healthcare | 71101-003 |
| OKeeffes Working Hands Pain Relief Skin Protectantallantoin, lidocaine hydrochloride | Allantoin .5 g/100g; Lidocaine hydrochloride 4 g/100g | CreamTopical | The Gorilla Glue Company/O'Keeffe's Company | 71564-009 |
| TopCare Pain Relieving Creamlidocaine hcl 4% | Lidocaine hydrochloride 40 mg/g | CreamTopical | Topco Associates, LLC | 76162-291 |
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