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 13 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
application number: M015
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal PadsWITCH HAZELWalmart, Inc.6dd8d3d9-5109-4869-917b-9521e9ba1ed02025-07-14WarningsExact identifier
application number: M015
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
application number: M015
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
application number: M015
medicated wipesWITCH HAZELMeijer Distribution Inc.ba0f3f9a-95d1-4d8a-86d1-2c25c945118c2025-07-11WarningsExact identifier
application number: M015
hemorrhoidal padsWITCH HAZELMeijer Distribution Inc.53e39d22-a89e-4f95-8c64-abeb50f72ce72025-07-11WarningsExact identifier
application number: M015
INVIGOR OHLIDOCAINENatureplex LLC7c7b536d-e41a-4017-9df9-982e2e9cfe4e2025-07-10WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF ANTI-ITCHHYDROCORTISONEHaleon US Holdings LLCd6148d77-ef6f-4552-b5ba-43b429923f192025-07-07WarningsExact identifier
application number: M015
Rectal Care CreamRECTAL CARE CREAMAllegiant Healthce585082-ad39-4b6f-a756-0d9a81a13eb82025-07-07WarningsExact identifier
application number: M015
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
application number: M015
TN Dickinsons Medicated Cooling Foam Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.deca8ae2-53a3-4c90-aa10-45354e2cdab82025-06-27WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
application number: M015
Phenylephrine HemorrhoidalHEMORRHOIDAL SUPPOSITORIESNeilmed Pharmaceuticals Inc.35ccb320-e902-3d1a-e063-6294a90a68d52025-06-20WarningsExact identifier
application number: M015
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
application number: M015
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLStrategic Sourcing Services LLCfb3bc359-b06b-4995-aa68-0117a639dff22025-06-11WarningsExact 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