FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1492398Internal RxNorm lookup
1492403Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a32741c-5e4a-40e5-b15a-8233c5bdb92bAvailable on FDA.report

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

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 6 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC8d9961f0-1ecf-d7fb-b6b4-856d636d68e12026-03-17WarningsExact identifier
application number: M015
Crane Safety BurnLIDOCAINECrane Safety LLC96d81566-6321-731e-e053-2995a90ad07d2026-03-16WarningsExact identifier
application number: M015
Signature Lidocaine Pain Relief Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4c56b3b3-33b3-a50e-e063-6394a90a955f2026-03-06WarningsExact identifier
application number: M015
WowDay Medicated Hemorrhoidal Flushable WipesMEDICATED HEMORRHOIDAL FLUSHABLE WIPESWowDay LLC4c603b27-4835-bc40-e063-6394a90a8ea22026-03-06WarningsExact identifier
application number: M015
Numb Fast HemorrhoidalLIDOCAINEOasis Plus LLCa00ffed7-8034-4cc0-87c4-3c793c1bcd6e2026-03-03WarningsExact identifier
application number: M015
Curist Lidocaine ReliefLIDOCAINE 5%Little Pharma, Inc.f562b57d-6592-93fa-e053-2995a90ae3e02026-03-02WarningsExact identifier
application number: M015
Therapain PlusMENTHOL ROLL-ONEpic Laboratories, LLC0249cfdf-b7c4-f27d-e063-6294a90aaa262026-03-02WarningsExact identifier
application number: M015
Liposomal Hemorrhoid MasterLIDOCAINE , PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.a1e15d2a-44b6-4d9c-89c2-0ff12285724e2026-03-02WarningsExact identifier
application number: M015
Equate Hemorrhoid ReliefLIDOCAINEWalmart Inc.48646860-ed5d-62a0-e063-6394a90abb232026-03-01WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELThe Kroger Co.bbf2efd7-f181-403b-ac5f-695f7ba158752026-02-27Warnings, Adverse reactionsExact identifier
application number: M015
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
application number: M015
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELBetter Living Brands, LLC0355edab-b6f7-4e59-bce1-cf6a8897b9892026-02-24Warnings, Adverse reactionsExact identifier
application number: M015
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
application number: M015
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.41d9d0b4-33e7-7e05-e063-6394a90a10112026-02-17WarningsExact identifier
application number: M015
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
application number: M015
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDALNUMBINGPutian Licheng District Zhijiancheng Trading Co., Ltd.4a5f59f1-c11a-e2eb-e063-6394a90a3e272026-02-10WarningsExact identifier
application number: M015
Numb MasterLIDOCAINEClinical Resolution Laboratory, Inc.0921c824-a8a9-4707-a480-c750192983f52026-02-09WarningsExact identifier
application number: M015
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
application number: M015

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