GRANULOTION Hemorrhoidal

Product NDC: 82897-293
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

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 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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier application number: M015
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	53f11395-f460-943f-e063-6294a90affef	2026-06-10	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Hemorrhoidal Wipes	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Rida LLC	f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3	2026-06-08	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	50f920da-b41a-480d-b3a0-df940caaee2d	2026-06-08	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	5356cf53-935d-a02f-e063-6394a90a6e5a	2026-06-05	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	HyVee Inc	b867f691-7a13-4659-b664-06aa36899310	2026-06-03	Warnings	Exact identifier application number: M015
Healcome Lidocaine Numbing Cream	LIDOCAINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	9b4eac02-1b1f-4630-92b4-b1d8c21abab5	2026-05-29	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile	TOLNAFTATE	Rida LLC	5517c43f-03b2-499a-a217-d9cba3fb9fd2	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus	TOLNAFTATE	Rida LLC	b4c5da66-5928-4352-ab90-fd46039e7955	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes	PRAMOXINE HYDROCHLORIDE	Rida LLC	bb29f156-37b8-400e-802b-3e2671cb7dc8	2026-05-27	Warnings	Exact identifier application number: M015
myDerm MEDICAL NEW Soothing Hemorrhoidal	WITCH HAZEL PENYLEPHRINE LIDOCAINE	Inspec Solutions	2ff42501-7730-42de-99dd-6fc53bbdf25f	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol	TOLNAFTATE	Rida LLC	8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8	2026-05-27	Warnings	Exact identifier application number: M015
Lidocaine Roll-on	LIDOCAINE	YYBA Corp	52d060df-2095-dd68-e063-6394a90a7740	2026-05-27	Warnings	Exact identifier application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	52a25b97-7721-6410-e063-6394a90a228f	2026-05-25	Warnings	Exact identifier application number: M015
Arlun LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5241c26b-6c91-65a5-e063-6394a90a2477	2026-05-20	Warnings	Exact identifier application number: M015
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5223b7fe-6aba-c77b-e063-6394a90ad27b	2026-05-18	Warnings	Exact identifier application number: M015
HEMORRHOIDAL WITH LIDOCAINE	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY, INC	4d870c68-9e72-464e-b0b8-900d0d661e43	2026-05-14	Warnings	Exact identifier application number: M015
Oxify	LIDOCAINE 5%	Weeks & Leo Compnay, INC.	51cd58f7-c1c9-f4e2-e063-6294a90ad970	2026-05-14	Warnings	Exact identifier application number: M015
Lidocaine anorectal cream	LIDOCAINE 5%	EveryMarket Inc	1604daec-812f-4684-ba98-fbcda07a7461	2026-05-12	Warnings	Exact identifier application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES	WITCH HAZEL	Haleon US Holdings LLC	485437a8-b2e9-4acf-a20e-edb1f08a9cae	2026-05-11	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