granulotion medicated

Generic: menthol, zinc oxide

Labeler: gl health, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name granulotion medicated
Generic Name menthol, zinc oxide
Labeler gl health, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

menthol 1.1 mg/g, zinc oxide 51 mg/g

Manufacturer
GL HEALTH, INC.

Identifiers & Regulatory

Product NDC 82897-544
Product ID 82897-544_259ec15b-2f69-be8c-e063-6294a90ad430
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2024-10-14

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82897544
Hyphenated Format 82897-544

Supplemental Identifiers

RxCUI
1492398
UPC
0862039000044
UNII
L7T10EIP3A SOI2LOH54Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name granulotion medicated (source: ndc)
Generic Name menthol, zinc oxide (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.1 mg/g
  • 51 mg/g
source: ndc
Packaging
  • 14 g in 1 TUBE (82897-544-00)
source: ndc

Packages (1)

82897-544-00 14 g in 1 TUBE (82897-544-00)

Ingredients (2)

menthol (1.1 mg/g) zinc oxide (51 mg/g)

Linked Drug Pages (1)

Granulotion Medicated ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "259ec15b-2f69-be8c-e063-6294a90ad430", "openfda": {"upc": ["0862039000044"], "unii": ["L7T10EIP3A", "SOI2LOH54Z"], "rxcui": ["1492398"], "spl_set_id": ["01701780-b160-415b-b34d-362237179475"], "manufacturer_name": ["GL HEALTH, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 g in 1 TUBE (82897-544-00)", "package_ndc": "82897-544-00", "marketing_start_date": "20241014"}], "brand_name": "Granulotion Medicated", "product_id": "82897-544_259ec15b-2f69-be8c-e063-6294a90ad430", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "82897-544", "generic_name": "MENTHOL, ZINC OXIDE", "labeler_name": "GL HEALTH, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Granulotion Medicated", "active_ingredients": [{"name": "MENTHOL", "strength": "1.1 mg/g"}, {"name": "ZINC OXIDE", "strength": "51 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241014", "listing_expiration_date": "20261231"}