FDA.reportPublic FDA data

ZHENG GU SHUI

Product NDC
59321-055
11-digit product format
593210055
Labeler code
59321
Product ID
59321-055_436cb650-b183-07c4-e063-6294a90ae29d
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL
Dosage form
LINIMENT
Route
PERCUTANEOUS; TRANSDERMAL
Labeler
GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Marketing end
2030-06-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
5.6; 5.6 g/100mL; g/100mL
NDC exclude flag
No
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
ZHENG GU SHUI

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)5.6 g/100mL
MENTHOL5.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366315Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17552943-4f11-42d6-ad41-fbc53f2bbd9aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59321-055-01ZHENG GU SHUI100 mL in 1 BOTTLELINIMENT1005
59321-055-02ZHENG GU SHUI88 mL in 1 BOTTLE, WITH APPLICATORLINIMENT885
59321-055-03ZHENG GU SHUI60 mL in 1 BOTTLE, SPRAYLINIMENT605
59321-055-04ZHENG GU SHUI30 mL in 1 BOTTLELINIMENT305
59321-055-05ZHENG GU SHUI12 mL in 1 BOTTLELINIMENT125

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
MENTHOLACTIVE MOIETYL7T10EIP3AZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
CYNANCHUM PANICULATUM ROOTINACTIVE INGREDIENTCZP7EPR012ZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
POLYGONUM CUSPIDATUM WHOLEINACTIVE INGREDIENT1VDG5Y5HS6ZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
ZANTHOXYLUM NITIDUM ROOTINACTIVE INGREDIENTL2CQZ81759ZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1
ZEDOARYINACTIVE INGREDIENT123C43G128ZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59321-055ZHENG GU SHUI (CAMPHOR, MENTHOL) LINIMENT [GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD]3Current NDC, Legacy NDC, 5 package rows20241127_17552943-4f11-42d6-ad41-fbc53f2bbd9a.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 87 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366315camphor 5.6 % / menthol 5.6 % Topical LotionPSN17552943-4f11-42d6-ad41-fbc53f2bbd9a5
1366315camphor 56 MG/ML / menthol 56 MG/ML Topical LotionSCD17552943-4f11-42d6-ad41-fbc53f2bbd9a5
1366315camphor 5.6 % / menthol 5.6 % Topical LotionSY17552943-4f11-42d6-ad41-fbc53f2bbd9a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59321-055-0159321005501100 mL in 1 BOTTLE (59321-055-01) 100 ml2025-06-012030-06-01NoNoCurrent
59321-055-025932100550288 mL in 1 BOTTLE, WITH APPLICATOR (59321-055-02) 88 ml2025-06-012030-06-01NoNoCurrent
59321-055-035932100550360 mL in 1 BOTTLE, SPRAY (59321-055-03) 60 ml2025-06-012030-06-01NoNoCurrent
59321-055-045932100550430 mL in 1 BOTTLE (59321-055-04) 30 ml2025-06-012030-06-01NoNoCurrent
59321-055-055932100550512 mL in 1 BOTTLE (59321-055-05) 12 ml2025-06-012030-06-01YesNoCurrent