FDA.reportPublic FDA data

China-Gel

Product NDC
76305-402
11-digit product format
763050402
Labeler code
76305
Product ID
76305-402_42c88b7e-2ce9-ffa3-e063-6394a90a0e58
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Camohor (synthetic)
Dosage form
CREAM
Route
TOPICAL
Labeler
China-Gel, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-11
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
50; 30 mg/g; mg/g
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
China-Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/g
CAMPHOR (SYNTHETIC)30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1312283Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7c5cb17-f7a2-7f57-e053-2995a90a40f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76305-402-01China-Gel113.5 g in 1 JARCREAM113.53
76305-402-02China-Gel453.6 g in 1 JARCREAM453.63
76305-402-03China-Gel170 g in 1 TUBECREAM1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76305-402CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC)) CREAM [CHINA-GEL, INC.]2Current NDC, Legacy NDC, 3 package rows20231220_d7c5cb17-f7a2-7f57-e053-2995a90a40f7.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 96 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLINGMENTHOLRENU LABORATORIES, LLC31e4fa2c-3a98-d618-e063-6394a90aec1c2025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCcc7cbf4a-8274-e463-e053-2995a90a51e02025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee018a-2c3c-3116-e053-2a95a90ac8d82025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee2b65-2759-0e62-e053-2a95a90a03782025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbdc7c7f3-ac98-8fe9-e053-2a95a90a26632025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
application number: M017
GREEN GUARD Topical Pain ReliefLIDOCAINE HCIUltra Distributors Incb6f0041c-47fc-0bcd-e053-2a95a90ab1f92025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebc1c6-93fb-efd6-e053-2995a90a25bb2025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 4MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0e9ac7c-a840-2e05-e053-2a95a90a33f12025-04-07WarningsExact identifier
application number: M017
CBDMEDIC Active Sport Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec5f47-2f8e-0558-e053-2a95a90aa7ca2025-04-07WarningsExact identifier
application number: M017
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592d29d-e275-a44d-e063-6294a90ab17d2025-04-02WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLC766b73f2-67bd-4d5c-805c-1057b3981ebf2025-04-02WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORAsclemed USA, Inc.d4d556c1-b64b-4b8e-8e4b-4f40eda242502025-04-01WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP31ce185e-07b7-d837-e063-6394a90a1fb02025-04-01WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1312283camphor 3 % / menthol 5 % Topical CreamPSNd7c5cb17-f7a2-7f57-e053-2995a90a40f73
1312283camphor 30 MG/ML / menthol 50 MG/ML Topical CreamSCDd7c5cb17-f7a2-7f57-e053-2995a90a40f73
1312283camphor 3 % / menthol 5 % Topical CreamSYd7c5cb17-f7a2-7f57-e053-2995a90a40f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76305-402-0176305040201113.5 g in 1 JAR (76305-402-01) 113.5 g2022-02-110000-00-00NoNoCurrent
76305-402-0276305040202453.6 g in 1 JAR (76305-402-02) 453.6 g2022-02-110000-00-00NoNoCurrent
76305-402-0376305040203170 g in 1 TUBE (76305-402-03) 170 g2022-02-110000-00-00NoNoCurrent