GranuLotion

Product NDC: 65121-885
11-digit product format: 651210885
Labeler code: 65121
Product ID: 65121-885_09d7554e-9396-9886-e063-6394a90a1a85
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Pure Source, LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-26
Substance: MENTHOL; ZINC OXIDE
Active strength: .11; 5.1 g/100g; g/100g
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65121-885		D	Discontinued by firm		2026-09-14
excluded package	package	65121-885	65121-885-23	D	Discontinued by firm		2026-09-14

Reported adverse events (FAERS/openFDA)#

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

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
65121-885-23	GranuLotion	1 in 1 BOX	LOTION	1		4
65121-885-23	GranuLotion	28.349 g in 1 BOTTLE	LOTION	28.349		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
LICORICE	INACTIVE INGREDIENT	61ZBX54883	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
POTASSIUM ALUM	INACTIVE INGREDIENT	1L24V9R23S	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65121-885	GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20231111_81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3.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 23 · 442 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flarestop Hemorrhoid Lidocaine	LIDOCAINE	Chelsea Pharmacceuticals LLC	b8a589f7-7131-4807-9bcb-84af3078e258	2026-09-10	Warnings	Exact identifier application number: M015
BCBCYC Numbing Cream	LIDOCAINE 5% NUMBING CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab36566-ba2f-06ef-e063-6394a90a71b5	2026-09-10	Warnings	Exact identifier application number: M015
5% Lidocaine 10g	5% LIDOCAINE	Chongqing Mandongzi Technology Co., Ltd	5b10530f-47cd-c4bd-e063-6294a90aaa0a	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum Strength	WITCH HAZEL	Amazon.com Services LLC	41d756f3-e523-ed14-e063-6394a90ab817	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	HEMORRHOIDAL WIPES WITH WITCH HAZEL	Better Living Brands LLC	adf26111-70ba-596c-e053-2995a90ac6f1	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	1fa7131a-8a94-47f4-826e-197a9cc5ec51	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
up and up medicated wipes manixim strength	GENTLE HEMORRHOIDAL CARE	Target Corporation	271eab2b-ed13-39f1-e054-00144ff88e88	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE	WITCH HAZEL CLOTH	The Kroger Co.	48c1598d-6667-446f-ac90-10ab945d0617	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel	WITCH HAZEL	Old East Main Co.	2055289d-962e-46a9-b371-b5bb93dd46b4	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Equate Hemorrhoidal Medicated Wipes	WITCH HAZEL	Walmart Inc.	8d57f054-77dc-4205-85f1-b65dcfde677b	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Lidocaine Cream	LIDOCAINE	InvaDerm Corporation	5a7273d1-1dbc-420e-e063-6294a90a8629	2026-09-01	Warnings	Exact identifier application number: M015
Lidocaine Phenylephrine	LIDOCAINE PHENYLEPHRINE	YYBA CORP	5a72a190-2129-411e-e063-6394a90a08c2	2026-09-01	Warnings	Exact identifier application number: M015
INICEI 5% LIDOCAINE Numbing Cream	5% LIDOCAINE NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5a65842f-27a1-268b-e063-6294a90a6054	2026-08-31	Warnings	Exact identifier application number: M015
AnievaLC	LIDOCAINE	Blackstone Products, LLC	ddaba14c-10de-44e2-ae13-9217e20cb48e	2026-08-29	Warnings	Exact identifier application number: M015
Norms Hemorrhoid Wipes	WITCH HAZEL	Totally Normal Company	5a1af50b-8d00-f589-e063-6394a90af86c	2026-08-28	Warnings	Exact identifier application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	59f0fa16-5eb0-e6bb-e063-6294a90aacf5	2026-08-26	Warnings	Exact identifier application number: M015
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

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	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492398	menthol 0.11 % / zinc oxide 5.1 % Topical Lotion	PSN	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492403	menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]	SBD	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492398	menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion	SCD	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492403	Granulotion (menthol 0.11 % / zinc oxide 5.1 % ) Topical Lotion	SY	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492398	Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion	SY	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4
1492403	Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]	SY	81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65121-885-23	65121088523	1 BOTTLE in 1 BOX (65121-885-23) / 28.349 g in 1 BOTTLE	1 bottle	2017-02-09	0000-00-00	No	No	Current