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
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
18; 6; .0225 g/60mL; g/60mL; g/60mL
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
Overtime
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860914Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25fec070-8587-42d1-ba6f-1a9c150acc98Available on FDA.report

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, Related label table
NDCEffectiveRelated label
27495-008-022023-07-12Overtime ® Pain Relief Lotion
27495-008-022023-07-12Overtime ® Pain Relief Lotion
27495-008-042023-07-12Overtime ® Pain Relief Lotion
27495-008-042023-07-12Overtime ® Pain Relief Lotion
27495-008-022023-01-30Overtime ® Pain Relief Lotion
27495-008-022023-01-30Overtime ® Pain Relief Lotion
27495-008-042023-01-30Overtime ® Pain Relief Lotion
27495-008-042023-01-30Overtime ® 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

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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017

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