FDA.reportPublic FDA data

Satohap

Product NDC
49873-065
11-digit product format
498730065
Labeler code
49873
Product ID
49873-065_0b7d6dc4-82df-04b0-e063-6394a90af9ec
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, dl-camphor, l-menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-02-05
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength
10; 5; 4 g/100mL; g/100mL; g/100mL
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
Satohap
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100mL
CAMPHOR (SYNTHETIC)5 g/100mL
LEVOMENTHOL4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup
BZ1R15MTK7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860825Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
348fde05-2797-4410-a1b2-99e64187c4feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-065-01Satohap1 in 1 CARTONLOTION14
49873-065-01Satohap45 mL in 1 BOTTLE, WITH APPLICATORLOTION454

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
salicylic acidACTIVE MOIETYO414PZ4LPZSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-065SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231203_348fde05-2797-4410-a1b2-99e64187c4fe.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 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsExact identifier
application number: M017
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsExact identifier
application number: M017
Abejas y Viboras Roll OnMETHYL SALICYLATEMenper Distributors Inc.bedf3b36-7def-099f-e053-2a95a90ac15b2025-07-22WarningsExact identifier
application number: M017
HealthWise Flexible 4% Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3869cc18-5494-6142-e063-6394a90a75e52025-07-22WarningsExact identifier
application number: M017
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALMMENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITED206d8c1e-eb5b-4ec7-a54e-8defc9fb9d272025-07-22WarningsExact identifier
application number: M017
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
application number: M017
Mountain Ice Sports Pain ReliefMENTHOL, CAMPHORMountainside Medical Equipment, Inc.c1f5512c-67b1-4ff0-b1a5-616e883d436f2025-07-21WarningsExact identifier
application number: M017
Stopain Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC9bac1869-8072-49bd-8568-a87a184d22002025-07-21WarningsExact identifier
application number: M017
Dr Kevin Khalili Pain Relief CreamMENTHOLDR. KHALILI LLC3a79b38c-9adc-60dd-e063-6394a90a5b302025-07-21WarningsExact identifier
application number: M017
ARTHRITIS PAIN RELIEFCAMPHOR, CAPSAICIN, METHYL SALICYLATEYUNNAN BAIYAO GROUP CO., LTD.671c57f0-3c6f-4416-bc81-f6930fef327b2025-07-21WarningsExact identifier
application number: M017
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
application number: M017
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
application number: M017
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860825camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical LotionPSN348fde05-2797-4410-a1b2-99e64187c4fe4
860825camphor 50 MG/ML / menthol 40 MG/ML / methyl salicylate 100 MG/ML Topical LotionSCD348fde05-2797-4410-a1b2-99e64187c4fe4
860825camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical LotionSY348fde05-2797-4410-a1b2-99e64187c4fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49873-065-01498730065011 BOTTLE, WITH APPLICATOR in 1 CARTON (49873-065-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR1991-02-050000-00-00NoNoCurrent