FDA.reportPublic FDA data

Menthol and Zinc Oxide

Product NDC
67777-234
11-digit product format
677770234
Labeler code
67777
Product ID
67777-234_2758f00d-dee3-2463-e063-6294a90a53c2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-11
Substance
MENTHOL; ZINC OXIDE
Active strength
.44; 21 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Menthol and Zinc Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.44 g/100g
ZINC OXIDE21 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
d0e43651-4215-465b-9ace-1bc23126b109Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-234-01Menthol and Zinc Oxide2 in 1 CASEOINTMENT213
67777-234-02Menthol and Zinc Oxide3.5 g in 1 POUCHOINTMENT3.513
67777-234-02Menthol and Zinc Oxide144 in 1 BOXOINTMENT14413
67777-234-03Menthol and Zinc Oxide24 in 1 CASEOINTMENT2413
67777-234-04Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT11313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-234-01GM - Gram67777-23446f9f4ca-c053-4d24-b2ad-3d98604bd9a112022-06-06
67777-234-02GM - Gram67777-234447b76a9-1e77-4aff-88fa-1bb5ade63fa612023-06-06
67777-234-03GM - Gram67777-234f5554336-50ce-465f-b28a-6f0c6606a3a912022-06-06
67777-234-04GM - Gram67777-234fc3d4854-e037-46ea-a476-8d37a8173e1d12023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
MENTHOLACTIVE MOIETYL7T10EIP3AMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
LANOLININACTIVE INGREDIENT7EV65EAW6HMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
PHENOLINACTIVE INGREDIENT339NCG44TVMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
THYMOLINACTIVE INGREDIENT3J50XA376EMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-234MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]13Current NDC, Legacy NDC, 5 package rows20241122_d0e43651-4215-465b-9ace-1bc23126b109.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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSNd0e43651-4215-465b-9ace-1bc23126b10913
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDd0e43651-4215-465b-9ace-1bc23126b10913
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYd0e43651-4215-465b-9ace-1bc23126b10913
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSYd0e43651-4215-465b-9ace-1bc23126b10913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-234-01677770234012 BOX in 1 CASE (67777-234-01) / 144 POUCH in 1 BOX (67777-234-02) / 3.5 g in 1 POUCH2 box2010-05-110000-00-00NoNoCurrent
67777-234-02677770234023.5 g in 1 POUCH3.5 gHistorical
67777-234-036777702340324 TUBE in 1 CASE (67777-234-03) / 113 g in 1 TUBE (67777-234-04) 24 tube2010-05-110000-00-00NoNoCurrent
67777-234-0467777023404113 g in 1 TUBE113 gHistorical