GRANULOTION Hemorrhoidal

Product NDC: 82897-293
Requested package NDC: 82897-293-00
11-digit product format: 828970293
Labeler code: 82897
Product ID: 82897-293_48c0cb84-caef-ea0d-e063-6394a90a87de
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: 2022-05-20
Substance: MENTHOL; ZINC OXIDE
Active strength: 1.1; 51 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: GRANULOTION Hemorrhoidal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1.1 mg/mL
ZINC OXIDE	51 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1492398	Internal RxNorm lookup
1492403	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
1a32741c-5e4a-40e5-b15a-8233c5bdb92b	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
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
82897-293-00	GRANULOTION Hemorrhoidal	3.3 mL in 1 PACKET	LOTION	3.3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82897-293	GRANULOTION HEMORRHOIDAL (MENTHOL, ZINC OXIDE) LOTION [GL HEALTH, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20231112_1a32741c-5e4a-40e5-b15a-8233c5bdb92b.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 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	Warnings	Exact identifier application number: M015
Moisture Barrier	MENTHOL 0.44%, ZINC OXIDE 20.6%	Walgreen Company	258f3392-0f42-21e8-e063-6294a90ae9ad	2026-07-22	Warnings	Exact identifier application number: M015
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	KORVIA GLOBAL Inc.	5690db03-4d62-9660-e063-6394a90a2fc0	2026-07-14	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE HCL	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-07-13	Warnings	Exact identifier application number: M015
Zmztuhua Numbing Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	56417dc6-c14b-ad17-e063-6294a90af7e5	2026-07-10	Warnings	Exact identifier application number: M015
Tina Davies IceCream	LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	6a2b3199-f405-4455-9a02-8885d24eef9c	2026-07-09	Warnings	Exact identifier application number: M015
Drs pharmacy HEMORRHOIDAL	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	164169b9-0627-9d1a-e063-6294a90ac46d	2026-07-09	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	H E B	09b814f4-86b5-4810-bf52-cc88396451c2	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	ADUSA Distribution, LLC	c50d0496-6f09-43c2-9383-3250885968c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	55260a3e-637a-c53b-e063-6394a90a1b09	2026-06-27	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	20c41406-99b2-bc89-e063-6294a90aed73	2026-06-25	Warnings	Exact identifier application number: M015
CalaSoothe	CALAMINE, MENTHOL, AND ZINC OXIDE	Dynarex Corporation	54f12005-acfe-4821-e063-6394a90ac304	2026-06-24	Warnings	Exact identifier application number: M015
tina davies IceCream Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd	2026-06-24	Warnings	Exact identifier application number: M015
Haemorrhoidal Pain Relief	ANORECTAL CREAM	NeilMed Pharmaceuticals Inc	544a9d6f-4eaa-613e-e063-6294a90a0c50	2026-06-15	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-06-15	Warnings	Exact identifier application number: M015
Dr.Seymour Butts Hemorrhoid	LIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4981c7d9-53ee-2a7b-e063-6394a90add01	2026-06-12	Warnings	Exact identifier application number: M015
ANIXIKE Numbing	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5b7c4c-feac-4eeb-e063-6294a90a5748	2026-06-11	Warnings	Exact identifier application number: M015
tina davies IceJelly Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	580559bf-d91f-4bb3-9c9b-b7e2cd0686fd	2026-06-11	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
1492403	Granulotion 0.11 % / 5.1 % Topical Lotion	PSN	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492398	menthol 0.11 % / zinc oxide 5.1 % Topical Lotion	PSN	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492403	menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]	SBD	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492398	menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion	SCD	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492403	Granulotion (menthol 0.11 % / zinc oxide 5.1 % ) Topical Lotion	SY	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492398	Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion	SY	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3
1492403	Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]	SY	1a32741c-5e4a-40e5-b15a-8233c5bdb92b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82897-293-00	82897029300	3.3 mL in 1 PACKET (82897-293-00)	3.3 ml	2022-05-20	0000-00-00	No	No	Current