Home NDC 82897-544 Granulotion Medicated
Product NDC 82897-544
11-digit product format 828970544
Labeler code 82897
Product ID 82897-544_259ec15b-2f69-be8c-e063-6294a90ad430
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler GL HEALTH, INC.
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-14
Substance MENTHOL; ZINC OXIDE
Active strength 1.1; 51 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Granulotion Medicated
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1.1 mg/g ZINC OXIDE 51 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1492398 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82897-544-00 Granulotion Medicated 14 g in 1 TUBE LOTION 14 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82897-544 GRANULOTION MEDICATED (MENTHOL, ZINC OXIDE) LOTION [GL HEALTH, INC.] 1 Current NDC, 1 package rows 20241031_01701780-b160-415b-b34d-362237179475.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 22 · 436 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dude Hemorrhoidal Wipes WITCH HAZEL Dude Products fdf408ef-9392-a812-e053-6394a90a0017 2026-08-25 Warnings Exact identifier application number: M015 Norms Medicated Wipes WITCH HAZEL Totally Normal Company 3a78e109-3f7c-fb19-e063-6394a90ae78e 2026-08-22 Warnings Exact identifier application number: M015 NERANTE Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 4dacd4f1-24d8-37ab-e063-6294a90a944d 2026-08-21 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 599b425a-0e96-76df-e063-6394a90a48ff 2026-08-21 Warnings Exact identifier application number: M015 Numb520Spray LIDOCAINE, PHENYLEPHRINE HCL Ebanel Laboratories, Inc. 350f0e25-fbdc-c0c0-e063-6294a90a50a0 2026-08-20 Warnings Exact identifier application number: M015 Flushable Hemorrhoidal Medicated Wipes Maximum Strength WITCH HAZEL Amazon.com Services LLC 41d756f3-e523-ed14-e063-6394a90ab817 2026-08-18 Warnings, Adverse reactions Exact identifier application number: M015 Gembooxt Topical Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 49951a3e-3b62-3d66-e063-6294a90a9360 2026-08-12 Warnings Exact identifier application number: M015 NumbMD Lidocaine Cream Anorectal(hemorrhoidal) LIDOCAINE 5% EveryMarket Inc 52379055-d017-4d98-e063-6294a90a196c 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 52369a41-820d-cd7a-e063-6394a90ac6d1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 51d370b4-1c34-d203-e063-6394a90a80b1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD 5% Lidocaine cream LIDOCAINE 5% EveryMarket Inc 507d0c2c-9517-40f8-e063-6394a90a1996 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) LIDOCAINE CREAM ANORECTAL EveryMarket Inc 483d81a3-7493-3391-e063-6394a90a2e3d 2026-08-12 Warnings Exact identifier application number: M015 Numbing Cream LIDOCAINE 100 KARMA INC 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 2026-08-12 Warnings Exact identifier application number: M015 Treatonic hemorrhoid treatment 5% LIDOCAINE 100 KARMA INC 41442fa7-c511-07ca-e063-6294a90a3992 2026-08-12 Warnings Exact identifier application number: M015 Lidocaine numbing cream 5% LIDOCAINE 100 KARMA INC 47380721-6633-4a50-e063-6394a90aca94 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 47dc7630-9a74-1989-e063-6294a90a50bb 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 49e6b69f-bd6e-b415-e063-6394a90a8e65 2026-08-12 Warnings Exact identifier application number: M015 Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing LIDOCAINE Putian Licheng District Zhijiancheng Trading Co., Ltd. 4a7be9eb-5e57-90e8-e063-6394a90aad9e 2026-08-08 Warnings Exact identifier application number: M015 THE SOLU TION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE SCALP TECH INC 58793581-8826-9a74-e063-6294a90a2465 2026-08-06 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 5457b3d7-e6b6-34a7-e063-6394a90aa240 2026-08-03 Warnings Exact identifier application number: M015
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82897-544-00 82897054400 14 g in 1 TUBE (82897-544-00) 14 g 2024-10-14 No No Current