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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLAmazon.com Services LLCadb638ec-4a7c-42f2-b249-0ac53a8dd4b22026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact 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