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 133 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact 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