FDA.reportPublic FDA data

Zinc Oxide with Menthol and White Petrolatum

Product NDC
87236-008
11-digit product format
872360008
Labeler code
87236
Product ID
87236-008_5102cba5-d73c-0fea-e063-6294a90a4305
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Zinc Oxide, White Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
MENTHOL; ZINC OXIDE; WHITE PETROLATUM
Active strength
.44; 20.625; 66.625 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage87236-00887236-008-04DDiscontinued by firm2026-10-21

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 with Menthol and White Petrolatum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.44 g/100g
ZINC OXIDE20.625 g/100g
WHITE PETROLATUM66.625 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
B6E5W8RQJ4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2728580Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f993fc0a-bd80-4345-a948-65ac03f910e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87236-008-04Zinc Oxide with Menthol and White Petrolatum113 g in 1 TUBEOINTMENT1133
87236-008-04Zinc Oxide with Menthol and White Petrolatum1 in 1 BOXOINTMENT13
87236-008-05Zinc Oxide with Menthol and White Petrolatum5 g in 1 PACKETOINTMENT53
87236-008-13Zinc Oxide with Menthol and White Petrolatum113 g in 1 TUBEOINTMENT1133
87236-008-44Zinc Oxide with Menthol and White Petrolatum5 g in 1 PACKETOINTMENT53
87236-008-44Zinc Oxide with Menthol and White Petrolatum144 in 1 CARTONOINTMENT1443

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 137 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact identifier
application number: M017
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2728580menthol 0.44 % / petrolatum, white 66.625 % / zinc oxide 20.625 % Topical OintmentPSNf993fc0a-bd80-4345-a948-65ac03f910e23
2728580menthol 0.0044 MG/MG / petrolatum 0.666 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDf993fc0a-bd80-4345-a948-65ac03f910e23
2728580menthol 0.0044 MG/MG / petrolatum 0.666 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYf993fc0a-bd80-4345-a948-65ac03f910e23
2728580menthol 0.44 % / petrolatum, white 66.625 % / zinc oxide 20.625 % Topical OintmentSYf993fc0a-bd80-4345-a948-65ac03f910e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-008-0487236000804113 g in 1 TUBE113 gHistorical
87236-008-05872360008055 g in 1 PACKET (87236-008-05) 5 g2025-12-01NoNoCurrent
87236-008-1387236000813113 g in 1 TUBE (87236-008-13) 113 g2025-12-01NoNoCurrent
87236-008-4487236000844144 PACKET in 1 CARTON (87236-008-44) / 5 g in 1 PACKET144 packet2025-12-01NoNoCurrent