FDA.reportPublic FDA data

ZHENG GU SHUI

Product NDC
59321-055
Requested package NDC
59321-055-01
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 71 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
application number: M017
AmericaineBENZOCAINEInsight Pharmaceuticals LLC4fd14452-0285-40c4-b835-36935c2056b22025-10-23WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
application number: M017
Family Care Muscle RubCAMPHOR, MENTHOL, AND METHYL SALICYLATEUnited Exchange Corp.63006bb5-76e8-eb64-e053-2991aa0a95ad2025-10-22WarningsExact identifier
application number: M017
Winco Cold and Hot Medicated Patch LargeMENTHOLWINCO FOODS, LLCaf0d86c4-f74e-2dbe-e053-2a95a90a74c12025-10-22WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
application number: M017
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
application number: M017
PAIN RELIEVINGLIDOCAINEMedhome Pharma Inc41cb1135-84e0-0c9a-e063-6294a90ada962025-10-22WarningsExact identifier
application number: M017
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAPSACINUnited Exchange Corp.ba9a3d72-db7a-4dd0-9220-f43c9ed871142025-10-21WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
application number: M017
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact 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