FDA.reportPublic FDA data

Extra Strength

Product NDC
70983-023
11-digit product format
709830023
Labeler code
70983
Product ID
70983-023_41ee90e0-d371-d1e7-e063-6394a90a42e3
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-13
Substance
MENTHOL; METHYL SALICYLATE
Active strength
94.41; 123.74 mg/mL; mg/mL
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
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL94.41 mg/mL
METHYL SALICYLATE123.74 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
LAV5U5022YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87d872b3-3231-d0f2-e053-2995a90a9d98Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-023-01Extra Strength1 in 1 BOXOIL18
70983-023-01Extra Strength45 mL in 1 BOTTLE, WITH APPLICATOROIL458
70983-023-02Extra Strength20 mL in 1 BOTTLE, WITH APPLICATOROIL208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-023EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [SAJE NATURAL BUSINESS INC.]7Current NDC, Legacy NDC, 3 package rows20231006_87d872b3-3231-d0f2-e053-2995a90a9d98.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 39 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact identifier
application number: M017
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain ReliefHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC869735f9-335e-4a5e-adfc-91167ae943c52026-01-19WarningsExact identifier
application number: M017
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
application number: M017
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
application number: M017
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
application number: M017
Equate Medicated Pain Relieving Patch, Large 6-CountCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Inc2c25cd7a-7e7b-5add-e063-6294a90a9e9b2026-01-19WarningsExact identifier
application number: M017
Equate Hydrocortione1% HYDROCORTISONEWalmart Inc.85b7f620-cc95-4333-b124-bbcc8fd5f7eb2026-01-19WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOLGURUNANDA, LLC3f1d146e-0d18-7f2f-e063-6394a90ab8162026-01-19WarningsExact identifier
application number: M017
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsExact identifier
application number: M017
Best Choice Targeted Warming Capsaicin Heat PatchCAPSAICINValu Merchandisers Company24ca40b7-e17b-42a3-bcc8-6861b9a5934a2026-01-18WarningsExact identifier
application number: M017
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsExact identifier
application number: M017
Neuropathy Pain Relief CreamMENTHOL CREAMOwell Naturals Brand, LLC48979093-2992-5fd8-e063-6394a90a815d2026-01-17WarningsExact identifier
application number: M017
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsExact identifier
application number: M017
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
application number: M017
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTWalgreens7088092c-3a5f-4fcc-84cc-931d238f75012026-01-15WarningsExact identifier
application number: M017
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
application number: M017
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-023-01709830023011 BOTTLE, WITH APPLICATOR in 1 BOX (70983-023-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR2019-05-130000-00-00NoNoCurrent
70983-023-027098300230220 mL in 1 BOTTLE, WITH APPLICATOR (70983-023-02) 20 ml2022-10-310000-00-00NoNoCurrent