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
2026-12-31

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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
application number: M017
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
application number: M017
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
application number: M017
LavaDerm AfterSunMENTHOLYoung Living Essential Oils, LC.4fcddcf1-36db-2f1a-e054-00144ff8d46c2026-04-15WarningsExact identifier
application number: M017
Arlun Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f8b60f9-03e3-e731-e063-6294a90a3b0a2026-04-15WarningsExact identifier
application number: M017
tuiwaro Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f66178c-95d9-8c6a-e063-6294a90a2c092026-04-14WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
application number: M017
Signature Pain Relief Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4f555b8f-5193-e685-e063-6294a90a7ba22026-04-13WarningsExact identifier
application number: M017
Deep Numbing CreamMENTHOLYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD7943559b-de10-4214-96dc-f9cbac828f462026-04-13WarningsExact identifier
application number: M017
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8465b443-abe9-78fb-e053-2a91aa0ac1d82026-04-13WarningsExact identifier
application number: M017
4JointzMENTHOLARP(USA) Pty Ltd94a5b5f5-abf7-40b3-9dd7-43e2c22f138e2026-04-13WarningsExact identifier
application number: M017
Sumifun Pain Relief CreamsMETHYL SALICLATE CAPSAICIN CAMPHORGuchutang Biotechnology (Longyan) Co., Ltd4f3dd96a-d843-d810-e063-6394a90a188e2026-04-12WarningsExact identifier
application number: M017
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Gel PatchCAPSAICIN, MENTHOLVeridian Healthcaref5484151-b6da-4f64-867f-87160a4ec2d62026-04-10WarningsExact 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