Over-the-counter drug · OTC MONOGRAPH DRUG
burn gel 01 NDC 82953-045
melaleuca alternifolia (tea tree) leaf oil · Melaleuca alternifolia (Tea tree) leaf oil 1 g/100g · Gel · Topical · Cosmuses Cosmetics (Ningbo) Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82953-045-01 | 8295300450182953004501 | .85 g in 1 POUCH (82953-045-01)Marketed from Apr 6, 2025 |
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)
- burn gel 01Suffix: 01
- Generic name (nonproprietary)
- melaleuca alternifolia (tea tree) leaf oil
- Active ingredients
- Melaleuca alternifolia (Tea tree) leaf oil — 1 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Cosmuses Cosmetics (Ningbo) Co., Ltd.NDC labeler code 82953
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 004
- Marketing start
- Listing expires
- Identifiers
- Product ID 82953-045_3227b643-a99e-6716-e063-6294a90a73b7SPL ID 3227b643-a99e-6716-e063-6294a90a73b7SPL set ID 3227bdc9-9323-68eb-e063-6294a90a29d2UNII VIF565UC2G
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
N482953004501followed by a unit qualifier and the quantityPackage 82953-0045-01. 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 Temporary soothes aches and pains associated with minor burn
Excerpt only. Read the full label for complete information.
About NDC 82953-045
- What is NDC 82953-045?
- 82953-045 is the product NDC for burn gel 01, Melaleuca alternifolia (Tea tree) leaf oil 1 g/100g gel, listed with the FDA by Cosmuses Cosmetics (Ningbo) Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- burn gel 01 (Melaleuca alternifolia (tea tree) leaf oil).
- What is the active ingredient?
- Melaleuca alternifolia (Tea tree) leaf oil.
- Who is the labeler?
- Cosmuses Cosmetics (Ningbo) Co., Ltd., NDC labeler code 82953. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for burn gel 01?
- 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 004
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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| Thompson Triple Antibioticbacitracin zinc, polymyxin b sulfate, neomycin sulfate | Polymyxin b sulfate 5000 [USP'U]/g + 2 more ingredients | OintmentTopical | Thompson | 73408-935 |
| Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | Safetec of America, Inc. | 61010-5600 |
| Thera Plus Original Strength Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 U/g + 2 more ingredients | OintmentTopical | Fourstar Group USA, Inc | 80684-198 |
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| Single Antibiotic with bacitracinbacitracin zinc | Bacitracin zinc 400 [USP'U]/g | OintmentTopical | Safetec of America | 61010-5601 |
| Major Clotrimazoleclotrimazole | Clotrimazole 10 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 66267-980 |
| American Safety First Aid Antispeticisopropyl alcohol | Isopropyl alcohol 700 mg/1000mL | SprayTopical | Orazen Inc | 71927-014 |
| Crane Safety Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | Crane Safety LLC | 73408-934 |
| First Aid Only Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 U/g + 2 more ingredients | OintmentTopical | Acme United Corporation | 0924-5618 |
| Triple Antibiotic Plus Pain Reliefbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | Chain Drug Marketing Association Inc. | 83324-036 |
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| Ever Ready First Aid Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | EVER READY FIRST AID | 72976-009 |
| InstantFoam Complete PUREalcohol | Alcohol 85.6 mL/100mL | LiquidTopical | SC Johnson Professional USA Inc. | 11084-309 |
| Fresh Startchloroxylenol | Chloroxylenol 3 mg/mL | SoapTopical | Pro Chem, Inc. | 63830-950 |
| berkley and jensen triple antibioticbacitracin zinc, neomycin, polymyxin b | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | BJWC | 68391-207 |
| Triple Antibioticbacitracin zinc, neomycin sulfate, and polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | Lidl US, LLC | 71141-134 |
| Hermon bed sore and pressure sore creamcalendula officinalis1x hpus 1.5% | Calendula officinalis flower 1.5 [hp_X]/120g | CreamTopical | Beautivity LLC | 85398-023 |
| Exchange Select First Aid Triple Anitbiotic Pain Relievingbacitracin, neomycin, polymyxin b, pramoxine hcl | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | Army & Air Force Exchange Service | 55301-123 |
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