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

Additional Listing Data#

Finished product
Yes
Brand name base
GRANULOTION Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.1 mg/mL
ZINC OXIDE51 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, SOI2LOH54Z
Rxcui1492398, 1492403

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
82897-293-00GRANULOTION Hemorrhoidal3.3 mL in 1 PACKETLOTION3.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82897-293GRANULOTION HEMORRHOIDAL (MENTHOL, ZINC OXIDE) LOTION [GL HEALTH, INC.]2Current NDC, Legacy NDC, 1 package rows20231112_1a32741c-5e4a-40e5-b15a-8233c5bdb92b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1492403Granulotion 0.11 % / 5.1 % Topical LotionPSN1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492398menthol 0.11 % / zinc oxide 5.1 % Topical LotionPSN1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492403menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SBD1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492398menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical LotionSCD1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492403Granulotion (menthol 0.11 % / zinc oxide 5.1 % ) Topical LotionSY1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492398Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical LotionSY1a32741c-5e4a-40e5-b15a-8233c5bdb92b3
1492403Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SY1a32741c-5e4a-40e5-b15a-8233c5bdb92b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82897-293-00828970293003.3 mL in 1 PACKET (82897-293-00) 3.3 ml2022-05-200000-00-00NoNoCurrent