Over-the-counter drug · OTC MONOGRAPH DRUG
Aluroderm Scar (Allantoin) NDC 84991-0316
Allantoin .0075 g/g · Patch · Cutaneous · Olakino Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84991-0316-1 | 84991031601 | 1 POUCH in 1 BOX (84991-0316-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCHMarketed from Dec 24, 2024 | |
| 84991-0316-5 | 84991031605 | 5 PATCH in 1 POUCH (84991-0316-5) / 8.5 g in 1 PATCHMarketed from Dec 24, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Aluroderm Scar
- Generic name (nonproprietary)
- allantoin
- Active ingredients
- Allantoin — .0075 g/g
- Dosage form
- Patch
- Route
- Cutaneous
- Labeler
- Olakino Therapeutics LLCNDC labeler code 84991
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Identifiers
- Product ID 84991-0316_2d94d970-563c-466c-e063-6294a90a93dbSPL ID 2d94d970-563c-466c-e063-6294a90a93dbSPL set ID 2a848dde-8fc4-ab10-e063-6294a90a2583RxCUI 2711688UNII 344S277G0ZUPC 0384991031619, 0384997031651
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N484991031601followed by a unit qualifier and the quantityPackage 84991-0316-01. 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 -Scar Management -Temporarily protects and helps relieve chapped or cracked skin
Excerpt only. Read the full label for complete information.
About NDC 84991-0316
- What is NDC 84991-0316?
- 84991-0316 is the product NDC for Aluroderm Scar (allantoin), Allantoin .0075 g/g patch, listed with the FDA by Olakino Therapeutics LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aluroderm Scar (Allantoin).
- What is the active ingredient?
- Allantoin.
- Who is the labeler?
- Olakino Therapeutics LLC, NDC labeler code 84991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aluroderm Scar?
- 1 other product NDC are listed under this name. See all Aluroderm Scar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aluroderm Scar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aluroderm Scarallantoin | Allantoin .0075 g/g | PatchCutaneous | Asclemed USA, Inc. | 76420-955 | 76420-0955-01 |
Other NDCs under M 016
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 |
|---|---|---|---|---|
| Bath Bomb 6-pack (Lavender)allantoin | Allantoin 3.1 g/555.3g; Sodium bicarbonate 248 g/555.3g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-508 |
| Nail Nourishing Penglycerin | Borneol .012 mg/12mg; Tea tree oil .0024 mg/12mg | LiquidTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-018 |
| Softlips Cherry, Raspberry, Vanilladimethicone | Dimethicone 20 mg/g | StickTopical | The Mentholatum Company | 10742-7002 |
| Foaming Facial Cleanserglycerin, niacinamide | Glycerin 40 mg/mL; Niacinamide 5 mg/mL | CreamTopical | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 75376-103 |
| Secura Protectivepetrolatum | Petrolatum 988.49 mg/g | OintmentTopical | Smith & Nephew Medical Ltd | 69740-316 |
| Dermaka Infants and Kids Multi Purpose Skin Protectantzinc oxide | Zinc oxide 250 mg/mL | OintmentTopical | Dermaka Skin Products LLC | 82240-014 |
| Bath Bomb 2-pack (Peppermint)allantoin | Allantoin 1.1 g/186.16g; Sodium bicarbonate 82 g/186.16g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-505 |
| XIMONTH Nail Repairs Patchesglycerin | Aloe barbadensis leaf .012 mg/60mg; Sophora flavescens root .012 mg/60mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-015 |
| Major Medi-Padswitch hazel | Witch hazel 50 g/100g | ClothTopical | Major Pharmaceuticals | 0904-6829 |
| terrasil Foreskin Reliefallantoin | Allantoin .5 g/100g | OintmentTopical | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 24909-058 |
| Petroleum Skin Protectantwhite petrolatum | Petrolatum 1 g/g | JellyTopical | Meijer, Inc. | 41250-069 |
| Rugby Zinc Oxide 20% | Zinc oxide 20 g/100g | OintmentTopical | Rugby Laboratories | 0536-1316 |
| Drs. DIAPER RASH MAXIMUM STRENGTHzinc oxide | Zinc oxide 10 g/100g; Dimethicone 1 g/100g | CreamTopical | OL PHARMA TECH, LLC Drs PHARMACY | 80489-576 |
| Bath Bomb 2-pack (Eucalyptus)allantoin | Allantoin 1.1 g/186.16g; Sodium bicarbonate 82 g/186.16g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-506 |
| Nail Repairs Patchesglycerin | Aloe barbadensis leaf .012 mg/60mg; Sophora flavescens root .012 mg/60mg | PatchTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-016 |
| Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15camphor (synthetic), white petrolatum, octinoxate, oxybenzone | — | Kit | Carma Laboratories, Inc. | 10210-0060 |
| Daily Moisturizingdimethicone | Dimethicone 1.3 kg/100mL | LotionTopical | CVS Pharmacy, Inc. | 69842-771 |
| Bath Bomb 6-pack (Lemon)allantoin | Allantoin 3.1 g/560.55g; Sodium bicarbonate 248 g/560.55g | Tablet, SolubleTopical | Carolina Cannabis Creations LLC | 82876-507 |
| XIMONTH Nail Nourishing Penglycerin | Tea tree oil .0024 mg/12mg | LiquidTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-017 |
| White Rose Petroleum Jellypetrolatum | Petrolatum 1000 mg/g | OintmentTopical | J. Strickland & Co. | 12022-031 |
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