NDC codes

FDA NDC Directory
Product NDC (as listed)10578-131Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10578-0131Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
10578-131-021057801310257 g in 1 TUBE (10578-131-02)Marketed from Nov 1, 2016
10578-131-0510578013105142 g in 1 JAR (10578-131-05)Marketed from Nov 1, 2016

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)
Dr. Blue
Generic name (nonproprietary)
menthol
Active ingredients
Menthol — 4.58 g/100g
Dosage form
Gel
Route
Topical
Labeler
Indiana Botanic GardensNDC labeler code 10578
Product type
Over-the-counter drug
Marketing category
OTC monograph (not final)Application part348
Marketing start
Listing expires
Identifiers
Product ID 10578-131_3b057467-ca8c-48c2-99ad-80a012b5f74bSPL ID 3b057467-ca8c-48c2-99ad-80a012b5f74bSPL set ID 1b1150bd-e087-4d8f-b0d6-0d935cf6e31eRxCUI 1549850UNII L7T10EIP3AUPC 0310578131052

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

N410578013102 followed by a unit qualifier and the quantity

Package 10578-0131-02. 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 relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains ■ provides cooling pain relief

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10578-131

What is NDC 10578-131?
10578-131 is the product NDC for Dr. Blue (menthol), Menthol 4.58 g/100g gel, listed with the FDA by Indiana Botanic Gardens. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dr. Blue (Menthol).
What is the active ingredient?
Menthol.
Who is the labeler?
Indiana Botanic Gardens, NDC labeler code 10578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dr. Blue?
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 part348

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under part348
ProductStrengthForm · routeLabelerProduct NDC
CVS Sore Muscle Rub Vanishing ScentmentholMenthol .025 g/gCreamTopicalCVS Pharmacy69842-712
Soundbodylidocaine, mentholLidocaine 40 mg/1; Menthol 10 mg/1PatchTopicalKareway Product, Inc.67510-0636
CVS Pharmacy Sensitive Medicated Creambenzocaine, benzalkonium chlorideBenzocaine .05 g/g; Benzalkonium chloride .0013 g/gCreamTopicalCVS Pharmacy69842-638
Med Aid Chest Rubmenthol and camphor and eucalyptus oilMenthol 1 g/100g + 2 more ingredientsOintmentTopicalBlue Cross Laboratories, Inc.22431-123
New Terocinmethyl salicylate, capsaicin, and mentholMethyl salicylate 25 g/100mL + 2 more ingredientsLotionTopicalPreferred Pharmaceuticals Inc.68788-7821
Arthritis Pain Relieving Creammenthol, methyl salicylateMenthol 12 g/1; Methyl salicylate 19.5 g/1CreamTopicalInternational Nature Nutraceuticals, Inc.51367-036
Rugby Muscle Rub Creammuscle rub creamMenthol, Unspecified form 100 mg/g; Methyl salicylate 150 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-8729
Pain Relief Creamtrolamine salicylateTrolamine salicylate 100 mg/gCreamTopicalALLURE LABS INC.62742-4091
Unburnlidocaine hydrochlorideLidocaine hydrochloride 2.5 g/100mLGelTopicalWater-Jel Technologies59898-500
Dollar General Medicated Pain Relief Patchcamphor, menthol, methyl salicylateCamphor (Synthetic) 3.1 g/100g + 2 more ingredientsPatchTopicalDOLGENCORP, LLC55910-907
Unburnlidocaine hydrochlorideLidocaine hydrochloride 2.5 g/100mLSprayTopicalWater-Jel Technologies59898-510
First Aid Burnbenzalkonium chloride, lidocaine hydrochlorideLidocaine hydrochloride .5 g/100g; Benzalkonium chloride .13 g/100gCreamTopicalWater-Jel Technologies59898-902
Fast Freezecamphor (natural), mentholCamphor (Natural) 2 mg/g; Menthol 35 mg/gGelTopicalNatural Essentials Inc.66902-000
Avedana Cool Hot IcementholMenthol 2 g/100gGelTopicalUnipack, Inc.43749-321
Cold Leaf Nutrition Muscle And Joint Pain ReliefmentholMenthol 37 mg/mLGelTopicalNATURAL ESSENTIALS, INC.66902-114
Icy FreezementholMenthol 35 mg/mLGelTopicalNATURAL ESSENTIALS, INC.66902-165
hydrocortisoneHydrocortisone 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-8078
Ultimate Topical Pain Relief Patchcapsaicin and menthol, unspecified formMenthol, Unspecified form 5 g/100g; Capsaicin .0375 g/100gPatchTopicalFoshan Aqua Gel Biotech Co.,Ltd.69159-910
Lidocaine Pain Relief Patchlidocaine and menthol, unspecified formMenthol, Unspecified form 1 g/100g; Lidocaine 4 g/100gPatchTopicalFoshan Aqua Gel Biotech Co.,Ltd.69159-920
Instaflex Pain Relief CreammentholMenthol 12.5 mg/gCreamTopicalAdaptive Health, LLC72779-100

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