FDA.reportPublic FDA data

Zinc Oxide and Menthol

Product NDC
87455-0001
11-digit product format
874550001
Labeler code
87455
Product ID
87455-0001_4b845517-657b-fec4-e063-6294a90afe6e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akron Formulations India Private Limited
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
MENTHOL; ZINC OXIDE
Active strength
.44; 20.6 g/100g; g/100g
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
Zinc Oxide and Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.44 g/100g
ZINC OXIDE20.6 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2123045Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b84556c-521f-eebd-e063-6394a90a8e1eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87455-0001-1Zinc Oxide and Menthol113 g in 1 TUBEOINTMENT1131

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
ndc (product): 87455-0001
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
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN4b84556c-521f-eebd-e063-6394a90a8e1e1
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD4b84556c-521f-eebd-e063-6394a90a8e1e1
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY4b84556c-521f-eebd-e063-6394a90a8e1e1
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY4b84556c-521f-eebd-e063-6394a90a8e1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87455-0001-187455000101113 g in 1 TUBE (87455-0001-1) 113 g2026-01-01NoNoCurrent