What is NDC 82897-544?

82897-544 is the product NDC for Granulotion Medicated, Menthol 1.1 mg/g; Zinc oxide 51 mg/g lotion, listed with the FDA by GL HEALTH, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Granulotion Medicated (Menthol, Zinc oxide).

GL HEALTH, INC., NDC labeler code 82897. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Granulotion Medicated?

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.

Granulotion Medicated NDC 82897-544 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82897-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82897-0544Add 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 NDC	11-digit (billing)	Package	Copy
82897-544-00	82897054400	14 g in 1 TUBE (82897-544-00)Marketed from Oct 14, 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): Granulotion Medicated
Generic name (nonproprietary): menthol, zinc oxide
Active ingredients: Menthol — 1.1 mg/gZinc oxide — 51 mg/g
Dosage form: Lotion
Route: Topical
Labeler: GL HEALTH, INC.NDC labeler code 82897
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 015
Marketing start: Oct 14, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Copper Ion Absorption (Physiologic effect)
Identifiers: Product ID 82897-544_259ec15b-2f69-be8c-e063-6294a90ad430SPL ID 259ec15b-2f69-be8c-e063-6294a90ad430SPL set ID 01701780-b160-415b-b34d-362237179475RxCUI 1492398UNII L7T10EIP3A, SOI2LOH54ZUPC 0862039000044
Pharmacologic class: Copper Absorption Inhibitor

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

N482897054400 followed by a unit qualifier and the quantity

Package 82897-0544-00. 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 Oct 29, 2024.

Indications (excerpt from the label)

USES: Helps relieve local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract the pain and may provide cooling sensation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82897-544

What is NDC 82897-544?: 82897-544 is the product NDC for Granulotion Medicated, Menthol 1.1 mg/g; Zinc oxide 51 mg/g lotion, listed with the FDA by GL HEALTH, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Granulotion Medicated (Menthol, Zinc oxide).
What is the active ingredient?: Menthol, Zinc oxide.
Who is the labeler?: GL HEALTH, INC., NDC labeler code 82897. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Granulotion Medicated?: 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 015

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

FDA NDC Directory listings under M 015
Product	Strength	Form · route	Labeler	Product NDC
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Nantong Health & Beyond Hygienic Products Inc.	43473-094
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Universal Distribution Center LLC	52000-438
5% Lidocaine 10g5% lidocaine	Lidocaine 5 g/100g	CreamTopical	Chongqing Mandongzi Technology Co., Ltd	88002-001
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0028
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0029
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-615
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0041
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-612
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-614
ADVANCED NUMB Topical Anestheticlidocaine hydrochloride	Lidocaine hydrochloride 50 mg/g	CreamTopical	Uber Scientific, LLC	71131-052
AER Pre-moistened Witch Hazel Padwitch hazel	Witch hazel 500 mg/mL	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-3250
AER Traveler Toweletteaer traveler	Witch hazel .5 g/1	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-4200
Americainebenzocaine	Benzocaine 5.6 g/28g	OintmentTopical	Insight Pharmaceuticals LLC	63736-375
AnievaLClidocaine	Lidocaine .05 g/g	CreamTopical	Blackstone Products, LLC	87798-001
ANIXIKE Numbinglidocaine4% numbing	Lidocaine 4 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-166
Arlun LIDOCAINE Creamlidocaine cream	Lidocaine 5 g/100g	CreamTopical	Guangzhou Jingliang Cosmetics Co., Ltd.	87408-021
Assured Bikini Smooth Creamlidocaine	Lidocaine 2 g/100g	CreamTopical	Zhejiang Jingwei Pharmaceutical Co., Ltd.	55621-011
Asteroidmenthol, petrolatum, zinc oxide	Menthol .098 g/28g + 2 more ingredients	OintmentTopical	HEALTHTEX LIMITED	84107-552
B-SURE Traveler Toweletteb-sure traveler	Witch hazel .5 g/g	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-9250
Barrier Protectant Creambarrier cream	Menthol 1 mg/g; Zinc oxide 200 mg/g	OintmentTopical	Cardinal Health	63517-003

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Granulotion Medicated (Menthol, zinc oxide) NDC 82897-544