FDA.reportPublic FDA data

Analgesic

Product NDC
61010-8201
11-digit product format
610108201
Labeler code
61010
Product ID
61010-8201_10981167-c8a2-e068-e063-6394a90ab165
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-01
Substance
MENTHOL
Active strength
70 mg/L
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
Analgesic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL70 mg/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79e3b0e7-4ba5-4b9d-a980-5b6f18dba802Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8201-0Analgesic0.059 L in 1 BOTTLE, SPRAYSPRAY0.0592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8201ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_79e3b0e7-4ba5-4b9d-a980-5b6f18dba802.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 120 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEBorden Company (Private) Limiteded79f14e-6b3d-4bf2-9c34-d019c1ba25822024-11-04WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEA-S Medication Solutions3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e32024-11-04WarningsExact identifier
application number: M017
Walgreens Ice Blue Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMWalgreen Company1c0ee442-ffd2-4f6c-aab2-f70e295378ad2024-11-04WarningsExact identifier
application number: M017
Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORMWalgreen Companyd5c79476-dde8-4a85-8878-bc2ac3a3d70b2024-11-04WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINESTRATUS PHARMACEUTICALS INC87a4f559-a4f6-4b9f-98de-b55b073a11c62024-11-01WarningsExact identifier
application number: M017
Walgreens Nerve Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMWalgreen Company83849eca-e02f-4b43-b3a7-b25e987e08a82024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica WhiteCAMPHORSanvall Enterprises, Inc192039a2-aed6-821b-e063-6394a90a7f292024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica ReforzadaCAMPHORSanvall Enterprises, Inc1921a4b1-cd36-195e-e063-6294a90a87932024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with CamphorCAMPHORSanvall Enterprises, Inc173db0e2-611f-55b9-e063-6394a90ac9872024-10-31WarningsExact identifier
application number: M017
Sanar Naturals CamphorCAMPHORSanvall Enterprises, Inc1921e851-cf83-0bdb-e063-6294a90a357f2024-10-31WarningsExact identifier
application number: M017
cortisoneHYDROCORTISONECVS Pharmacyc766deac-d993-4e48-a5c3-4cfde7338dff2024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Lavender AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company6c7b39c8-5b65-430a-a529-5b6b14adce182024-10-31WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61010-8201-061010820100.059 L in 1 BOTTLE, SPRAY (61010-8201-0) 2018-09-010000-00-00NoNoCurrent