FDA.reportPublic FDA data

GranuLotion

Product NDC
65121-885
11-digit product format
651210885
Labeler code
65121
Product ID
65121-885_482d946f-62b5-0db3-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Pure Source, LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-26
Marketing end
0000-00-00
Substance
MENTHOL; ZINC OXIDE
Active strength
0 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65121-885DDiscontinued by firm2026-11-13
excluded packagepackage65121-88565121-885-23DDiscontinued by firm2026-11-13

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 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]4Legacy NDC, 2 package rows20231111_81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3.zip

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