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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact 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