FDA.reportPublic FDA data

GranuLotion

Product NDC
65121-885
Requested package NDC
65121-885-23
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65121-88565121-885-23DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65121-885-23GranuLotion1 in 1 BOXLOTION14
65121-885-23GranuLotion28.349 g in 1 BOTTLELOTION28.3494

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
MENTHOLACTIVE MOIETYL7T10EIP3AGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
LICORICEINACTIVE INGREDIENT61ZBX54883GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
POTASSIUM ALUMINACTIVE INGREDIENT1L24V9R23SGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1
WATERINACTIVE INGREDIENT059QF0KO0RGRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65121-885GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE, LLC]4Current NDC, Legacy NDC, 2 package rows20231111_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 · 436 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
NERANTE Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.4dacd4f1-24d8-37ab-e063-6294a90a944d2026-08-21WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015
Numb520SprayLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.350f0e25-fbdc-c0c0-e063-6294a90a50a02026-08-20WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-08-18Warnings, Adverse reactionsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL NumbingLIDOCAINEPutian Licheng District Zhijiancheng Trading Co., Ltd.4a7be9eb-5e57-90e8-e063-6394a90aad9e2026-08-08WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1492403Granulotion 0.11 % / 5.1 % Topical LotionPSN81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492398menthol 0.11 % / zinc oxide 5.1 % Topical LotionPSN81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492403menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SBD81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492398menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical LotionSCD81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492403Granulotion (menthol 0.11 % / zinc oxide 5.1 % ) Topical LotionSY81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492398Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical LotionSY81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34
1492403Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SY81b70fd5-2fc0-4962-b9a0-ff0c961dd9e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-885-23651210885231 BOTTLE in 1 BOX (65121-885-23) / 28.349 g in 1 BOTTLE1 bottle2017-02-090000-00-00NoNoCurrent