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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
01701780-b160-415b-b34d-362237179475	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Meijer Distribution Inc	14319ba4-3bce-497c-a380-65bd24defc5d	2024-10-17	Warnings	Exact identifier application number: M015
equate hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	581dd76f-d052-4448-8139-9a2e31891b25	2024-10-17	Warnings	Exact identifier application number: M015
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier application number: M015
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Topco Associates LLC	5e13da07-48cf-40bc-bb11-fd891886cbea	2024-10-14	Warnings	Exact identifier application number: M015
hemorrhoidal maximum strength pain relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Kroger Company	3c8f90e2-fecf-4439-9faa-81a32ffe4753	2024-09-26	Warnings	Exact identifier application number: M015
equate hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Wal-Mart Stores Inc	5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d	2024-09-26	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal Pain Relief	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Walgreens	e79ed7ae-0d06-2f88-e053-2995a90a1e35	2024-09-20	Warnings	Exact identifier application number: M015
hemorrhoidal relief	COCOA BUTTER, PHENYLEPHRINE HCL	Rite Aid Corporation	ddafbdca-32c2-49c1-83d3-35b4155958c9	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier application number: M015
Up and Up Hemorrhoid MAX STRENGTH	14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM	Target Corporation	867677b5-fd1d-449e-966e-1de0b5c98afb	2024-08-08	Warnings	Exact identifier application number: M015
Soothing Hemorrhoidal Wipes 50 Witch Hazel	WITCH HAZEL	The Honey Pot Company LLC	1ea202f5-e228-b3f2-e063-6294a90a16c1	2024-08-01	Warnings	Exact identifier application number: M015
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Exact identifier application number: M015
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier application number: M015
MegaBabe Butt Stuff Hemorrhoidal	COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	MEGABABE, LLC	01c156ff-69f9-4d5e-a9ea-abbc52d4afff	2024-06-12	Warnings	Exact identifier application number: M015
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1492398	menthol 0.11 % / zinc oxide 5.1 % Topical Lotion	PSN	01701780-b160-415b-b34d-362237179475	1
1492398	menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion	SCD	01701780-b160-415b-b34d-362237179475	1
1492398	Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion	SY	01701780-b160-415b-b34d-362237179475	1

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