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

Additional Listing Data#

Finished product: Yes
Brand name base: GranuLotion
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.11 g/100g
ZINC OXIDE	5.1 g/100g

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
81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3	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
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 22 · 425 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
HEMORRHOIDALCREAMPROCURE	PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL	TWIN MED, LLC	e9c44756-1c98-41be-e053-2995a90a35b4	2026-08-03	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Exact identifier application number: M015
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Exact identifier application number: M015
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
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	561c601f-c2cd-f09c-e063-6294a90adb45	2026-07-08	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

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