FDA.reportPublic FDA data

HYSAN PAIN RELIEVER

Product NDC
63255-111
11-digit product format
632550111
Labeler code
63255
Product ID
63255-111_4c732ba1-d363-4a0e-8b3b-235b1c505701
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Dosage form
OIL
Route
TOPICAL
Labeler
HYSAN PHARMACEUTICAL CO LTD
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC)
Active strength
37; 10 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
HYSAN PAIN RELIEVER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE37 g/100mL
CAMPHOR (SYNTHETIC)10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal 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
1860084Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bad73234-c204-40a8-8176-45c75ae500c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63255-111-01HYSAN PAIN RELIEVER40 mL in 1 BOTTLE, GLASSOIL402
63255-111-02HYSAN PAIN RELIEVER3 mL in 1 BOTTLE, GLASSOIL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63255-111HYSAN PAIN RELIEVER (METHYL SALICYLATE, CAMPHOR (SYNTHETIC)) OIL [HYSAN PHARMACEUTICAL CO LTD]2Current NDC, Legacy NDC, 2 package rows20241009_bad73234-c204-40a8-8176-45c75ae500c8.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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860084camphor 10 % / methyl salicylate 37 % Topical OilPSNbad73234-c204-40a8-8176-45c75ae500c82
1860084camphor 100 MG/ML / methyl salicylate 370 MG/ML Topical OilSCDbad73234-c204-40a8-8176-45c75ae500c82
1860084camphor 10 % / methyl salicylate 37 % Topical OilSYbad73234-c204-40a8-8176-45c75ae500c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63255-111-016325501110140 mL in 1 BOTTLE, GLASS (63255-111-01) 40 ml2021-02-010000-00-00NoNoCurrent
63255-111-02632550111023 mL in 1 BOTTLE, GLASS (63255-111-02) 3 ml2021-02-010000-00-00NoNoCurrent