FDA.reportPublic FDA data

Analgesic

Product NDC
61010-8200
11-digit product format
610108200
Labeler code
61010
Product ID
61010-8200_12b7defb-8710-5fd7-e063-6294a90a8a03
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
2011-10-26
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
70 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM70 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1086713

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-8200-12024-04-09C16284748780-19d75b9cf-e7c5-f424-e053-dadaa90a57ce61010-8200, PAIN SPRAY
61010-8200-12020-01-31C16284748780-19d75b9cf-e7c5-f424-e053-dadaa90a57ce61010-8200, PAIN SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8200-1Analgesic118 mL in 1 BOTTLE, SPRAYSPRAY1182

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3AANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
mentholACTIVE MOIETYL7T10EIP3AANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
coconut oilINACTIVE INGREDIENTQ9L0O73W7LANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
eucalyptus oilINACTIVE INGREDIENT2R04ONI662ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
methyl salicylateINACTIVE INGREDIENTLAV5U5022YANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
peppermint oilINACTIVE INGREDIENTAV092KU4JHANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8200ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240410_b0f4010c-995f-40e1-aa40-92760e697a61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086713menthol 7 % Topical SprayPSNb0f4010c-995f-40e1-aa40-92760e697a612
1086713menthol 70 MG/ML Topical SpraySCDb0f4010c-995f-40e1-aa40-92760e697a612
1086713menthol 7 % Topical SpraySYb0f4010c-995f-40e1-aa40-92760e697a612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61010-8200-161010820001118 mL in 1 BOTTLE, SPRAY (61010-8200-1) 118 ml2011-10-26NoNoCurrent