FDA.reportPublic FDA data

Overtime

Product NDC
27495-008
11-digit product format
274950008
Labeler code
27495
Product ID
27495-008_4349c0a8-8020-da2e-e063-6394a90a78d8
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol and Capsaicin
Dosage form
LOTION
Route
TOPICAL
Labeler
Physicians Science & Nature Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
CAPSAICIN; MENTHOL; METHYL SALICYLATE
Active strength
.0225; 6; 18 g/60mL; g/60mL; g/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.0225 g/60mL
MENTHOL6 g/60mL
METHYL SALICYLATE18 g/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A, LAV5U5022Y
Rxcui860914

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27495-008-022023-07-12C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-022023-07-12C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-042023-07-12C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-042023-07-12C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-022023-01-30C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-022023-01-30C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-042023-01-30C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion
27495-008-042023-01-30C16284748780-1f386c64a-3e3a-0266-e053-dadaa90a7c1aOvertime ® Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27495-008-02Overtime50 in 1 CARTONLOTION5010
27495-008-02Overtime60 mL in 1 BOTTLELOTION6010
27495-008-04Overtime50 in 1 CARTONLOTION5010
27495-008-04Overtime120 mL in 1 BOTTLELOTION12010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
BORAGE OILINACTIVE INGREDIENTF8XAG1755SOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62OVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2OVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999ROVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKOVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27495-008OVERTIME (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PHYSICIANS SCIENCE & NATURE INC.]8Current NDC, Legacy NDC, 4 package rows20241220_25fec070-8587-42d1-ba6f-1a9c150acc98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860914capsaicin 0.0375 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN25fec070-8587-42d1-ba6f-1a9c150acc9810
860914capsaicin 0.375 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD25fec070-8587-42d1-ba6f-1a9c150acc9810
860914capsaicin 0.0375 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY25fec070-8587-42d1-ba6f-1a9c150acc9810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27495-008-022749500080250 BOTTLE in 1 CARTON (27495-008-02) / 60 mL in 1 BOTTLE50 bottle2007-01-010000-00-00NoNoCurrent
27495-008-042749500080450 BOTTLE in 1 CARTON (27495-008-04) / 120 mL in 1 BOTTLE50 bottle2007-01-010000-00-00NoNoCurrent