FDA.reportPublic FDA data

Doctor Hoys Pain Relief Gel

Product NDC
75638-010
Requested package NDC
75638-010-01
11-digit product format
756380010
Labeler code
75638
Product ID
75638-010_4769df6d-225f-5a0d-e063-6394a90af652
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR (SYNTHETIC)
Dosage form
GEL
Route
TOPICAL
Labeler
Dynamic Blending Specialists, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-01
Marketing end
2028-04-13
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
50; 50 mg/mL; mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75638-01075638-010-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75638-01075638-010-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75638-01075638-010-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Doctor Hoys Pain Relief Gel

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/mL
CAMPHOR (SYNTHETIC)50 mg/mL

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
797500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
75638-010-00Doctor Hoy's Pain Relief Gel
75638-010-01Doctor Hoy's Pain Relief Gel
75638-010-02Doctor Hoy's Pain Relief Gel
75638-010-03Doctor Hoy's Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75638-010-00Doctor Hoys Pain Relief Gel89 mL in 1 TUBEGEL894
75638-010-01Doctor Hoys Pain Relief Gel177 mL in 1 TUBEGEL1774
75638-010-02Doctor Hoys Pain Relief Gel946 mL in 1 TUBEGEL9464
75638-010-03Doctor Hoys Pain Relief Gel1893 mL in 1 TUBEGEL18934

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75638-010DOCTOR HOYS PAIN RELIEF GEL (MENTHOL, CAMPHOR (SYNTHETIC)) GEL [DYNAMIC BLENDING SPECIALISTS, INC.]3Current NDC, 4 package rows20250201_50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8.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 35 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
application number: M017
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
application number: M017
NATURULZ ULTIMATE HEALINGCAPSAICINI SHAY COSMETICS INC436eac74-d07f-d718-e063-6394a90a86602026-02-03WarningsExact identifier
application number: M017
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEEagle Indo Pharma, PT888f88fc-dcaf-93e5-e053-2a95a90a20e12026-02-02WarningsExact identifier
application number: M017
Wang Prom Green Balm by Wang PromWANG PROM WANG PROM GREEN BALM BY VENTURE GO LLCAMBIENCE FAMILY INC4a063898-16a4-695a-e063-6394a90adb932026-02-02WarningsExact identifier
application number: M017
Numbsure LIDOCAINELIDOCAINE 4%Hambli Limited43a65a12-ef2a-4608-e063-6394a90a82ea2026-01-31WarningsExact identifier
application number: M017
Collajoint Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEF GEL PATCHHenan Enokon Medical Instrument Co., Ltd.44e27e7f-992f-d194-e063-6294a90a94e42026-01-31WarningsExact identifier
application number: M017
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797500camphor 5 % / menthol 5 % Topical GelPSN50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a84
797500camphor 0.05 MG/MG / menthol 0.05 MG/MG Topical GelSCD50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a84
797500camphor 5 % / menthol 5 % Topical GelSY50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75638-010-0175638001001177 mL in 1 TUBE (75638-010-01) 177 ml2023-03-012028-01-24NoNoHistorical